FDA Adverse Event
Malfunction
Summary report: N
*
MDR report key: 3032376
·
Received March 13, 2013
Report
- Report Number
- 3032376
- Event Type
- Malfunction
- Date Received
- March 13, 2013
- Date of Event
- March 13, 2013
- Report Date
- March 13, 2013
- Manufacturer
- ZOLL MEDICAL CORPORATION
- Product Code
- MKJ
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- CA, US
Narratives
Description of Event or Problem · 1
THE ZOLL R SERIES DEFIB HAVE A POWER CORD QUICK RELEASE IN THE BACK. THE CORD IS OUT OF VIEW UNLESS THE DEVICE IS LIFTED UP. OFTEN THE POWER CORD WILL BECOME SLIGHTLY PULLED APART AND CAUSE THE UNIT TO NOT CHARGE. IT IS DIFFICULT FOR STAFF TO FIND OUT WHY THE UNIT WILL NOT CHARGE BECAUSE THE CONNECTOR DOES NOT COMPLETELY SEPARATE AND IS HIDDEN FROM VIEW. THE STAFF ARE USUALLY UNAWARE THAT THERE IS THIS CONNECTOR UNDER THE DEVICE.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 106323 | * | AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) | MKJ | ZOLL MEDICAL CORPORATION | R SERIES | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |