DEFIGARD TOUCH 7 (2019-12-16)
- Starting date:
- December 16, 2019
- Posting date:
- January 6, 2020
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-72017
Last updated: 2020-01-07
Affected Products
DEFIGARD TOUCH 7
Reason
In rare cases, it is possible that a defibrillation shock cannot be delivered, the device has an electrode fault although no electrode fault is present. This results in an internal safety discharge, the delivery of the shock is canceled. The cause of the electrode fault message may be an impedance loop between the battery charge contacts of the defibrillator and the patient. This is possible when the device rests on the patient during use (with the charging contacts in contact with the skin), or when the patient and the device are lying on a wet floor, and the charging contacts come into contact with the ground (for example, the patient and the device are on wet ground, or in the grass)
Affected products
DEFIGARD TOUCH 7
Lot or serial number
Serial # 128968000916
Serial # 128969000990
Model or catalog number
1-128-9900
Companies
- Manufacturer
-
Schiller Medical
4 Rue Louis Pasteur
Wissembourg
67162
FRANCE