Cardiologists: Medical devices - what should I report?

A patient attends the outpatient clinic one afternoon but collapses at reception. The defibrillator is brought out, but when it is turned on, there is a smell of burning plastic, and it does not function. Unfortunately, the patient dies.

Is an external defibrillator a medical device?
Yes, and it should have an appropriate CE mark. All medical devices must be CE marked, unless they are undergoing a clinical trial. Any trial on a medical device which is not CE-marked, and intended for commercial use, must be approved by the MHRA before it commences.

Should this incident be reported to the MHRA?
Yes. The defibrillator failed to function as intended and this resulted in the death of a patient. Whether or not the patient would have died even if the defibrillator had functioned correctly is not relevant.

When should this incident be reported?
This should be reported immediately. There should be no delay, as if there is a defect with the manufacturing of a batch of defibrillators or their programming, immediate reporting may result in the re-call of a batch and thus the prevention of similar incidents.

At the end of a coronary angiogram procedure, you close the femoral access site with a vascular closure device. Two hours later, the patient’s blood pressure drops; he is returned to theatre and a vascular surgeon repairs two tears in the artery.

Is the vascular closure equipment a medical device?
Yes. In addition to the implant itself, the associated insertion device, being an accessory, is also a medical device.

Should this incident be reported to the MHRA?  
Yes. The patient has clearly suffered harm as a result.

What else should the clinical team ensure is done?
The device should be isolated, if found and, if possible, a lot number noted. In addition to notifying the MHRA, it is always appropriate to notify the device manufacturer in order to speed up resolution of the underlying problem. If there is a possibility that the incident is related to a user error, the MHRA is still interested in the details being reported – others may be having the same issue due to poor instructions for use; an area which we can work with manufacturers to improve.

A 27- year- old female, who had a pacemaker implanted 6 months earlier, attends your clinic, but the battery indicator demonstrates unexpected early depletion. You replace the device and no harm is suffered by the patient.

Is the pacemaker a medical device?
Yes. In addition to the pacemaker, the interrogating device and all associated computer software are also medical devices.

Should this incident be reported to the MHRA? 
Yes. Although no harm directly resulted from the early unexpected battery depletion, the patient underwent a further medical procedure as a result and was subjected to additional risk during the period of the depletion.

What else should the clinical team ensure is done?
The device should be quarantined and, on request, returned to the manufacturer. Investigation of the incident by the MHRA is performed in conjunction with the manufacturer who will need to examine the device and provide the MHRA with a report.

A 75- year- old man with an implantable cardiac defibrillator receives 4 inappropriate shocks while working in the garden. On arriving at hospital via the ambulance, the device is interrogated and indicates increased impedence and oversensing. A lead is found to be fractured and is replaced.

Is the lead a medical device?
Yes. Both the implantable cardiac defibrillator and the associated leads are medical devices.

Should this incident be reported to the MHRA?
Yes. Significant harm was caused to the patient and he underwent an additional high risk procedure. Although lead fracture is a known risk, it is always important to report occurrences, particularly any incident involving death or serious injury or potential for death or serious injury.

What else should those present in the clinic do?
It is again important to quarantine the device, whether or not it was further fractured during the removal procedure, to ensure that the manufacturer will be able to examine it later on.

While a patient was being transferred from the trolley to the examination table in the catheter laboratory, prior to elective insertion of a stent, the trolley suddenly dropped six inches, despite nobody being near the controls. The patient fell off the trolley and fractured his hip on the floor and the procedure was cancelled.

Is the bed a medical device?
Yes. In addition to beds, wheelchairs, Zimmer frames, many walking sticks and other mobility aids are classed as medical devices.

Should this incident be reported to the MHRA?
Yes. Incidents of serious injury or death associated with hospital beds and wheelchairs are not uncommon. Any malfunction or adverse event should be reported.

What else should the clinical team ensure is done?
The bed should be taken out of use, and isolated. In addition to notifying the MHRA, it is always appropriate to notify the device manufacturer in order to speed up resolution of the underlying problem. The MHRA always tries to work with manufacturers when investigating adverse events – they want their devices to remain safe just as much as we do.