FDA Adverse Event
Malfunction
Summary report: N
E SERIES DEFIBRILLATOR
MDR report key: 6149128
·
Received December 6, 2016
Report
- Report Number
- 1220908-2016-03028
- Event Type
- Malfunction
- Date Received
- December 6, 2016
- Report Date
- November 17, 2016
- Manufacturer
- ZOLL MEDICAL CORPORATION
- Product Code
- MKJ
- PMA / PMN Number
- K042007
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE DEVICE FOR EVALUATION AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.
Additional Manufacturer Narrative · 1
THE DEVICE WAS RETURNED TO ZOLL MEDICAL (B)(4); THE MALFUNCTION WAS DUPLICATED AND THE MFC CONNECTOR WAS FOUND TO BE UNSEATED TO THE CONNECTOR PANEL. THE MFC CONNECTOR WAS RESEATED AND THE MFC RETAINER WAS INSTALLED TO REMEDY THE CONDITION. ANALYSIS FOR REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.
Description of Event or Problem · 1
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE INAPPROPRIATELY DISPLAYED AN "ATTACH PADS" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 797950 | E SERIES DEFIBRILLATOR | E SERIES | MKJ | ZOLL MEDICAL CORPORATION | E SERIES | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |