Please note: In October and November 2010, the MHRA moved from its Market Towers address to a new location on Buckingham Palace Road. Please go to the contact us section of the website for updated contact details.
Page 1
| Issued: 18 February 2009 at 12:00 |
Ref: MDA/2009/013
|
|
|
Immediate action |
|
|
Immediate action update |
|
Action |
|
|
Action update |
|
Device:
|
|
Problem: Following defibrillation the observed ECG waveform may show a 'flatline' (asystole). This may result in inappropriate treatment that could be detrimental to the patient. |
|
Action:
|
| Action by: Users of defibrillators and ECG equipment. Those responsible for medical device management. |
|
Contact: Manufacturer |
|
Action deadlines for the Central Alerting System (CAS)
|
|
|
Deadline (action underway): 25 February 2009
|
Deadline (action complete): 18 March 2009
|
MDA/2009/013 - Short term adult and paediatric ECG monitoring electrodes manufactured by Unomedical 
