FDA Adverse Event
Malfunction
Summary report: N
E SERIES DEFIBRILLATOR
MDR report key: 2222015
·
Received August 17, 2011
Report
- Report Number
- 1220908-2011-02339
- Event Type
- Malfunction
- Date Received
- August 17, 2011
- Date of Event
- July 21, 2011
- Report Date
- July 27, 2011
- Manufacturer
- ZOLL MEDICAL CORP
- Product Code
- MKJ
- PMA / PMN Number
- K042007
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ZOLL MEDICAL CORP HAS RECEIVED THE PRODUCT AND WILL BE PROVIDING A FOLLOW-UP REPORT WHEN OUR INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO MONITOR THE HEART RHYTHM OF A (B)(6), MALE PT WITH CHEST PAINS, THE DEVICE'S DISPLAY WAS FLICKERING. THE DEVICE WAS TURNED OFF/ON AND THE DEVICE'S DISPLAY WAS STILL FLICKERING AND CLINICAL INFORMATION COULD NOT BE READ. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PT DUE TO THE REPORTED MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | E SERIES DEFIBRILLATOR | E SERIES | MKJ | ZOLL MEDICAL CORP | E SERIES | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR |