FDA Adverse Event
Malfunction
Summary report: N
E SERIES DEFIBRILLATOR
MDR report key: 3830164
·
Received May 9, 2014
Report
- Report Number
- 1220908-2014-01121
- Event Type
- Malfunction
- Date Received
- May 9, 2014
- Report Date
- April 22, 2014
- Manufacturer
- ZOLL MEDICAL CORP
- Product Code
- MKJ
- PMA / PMN Number
- K042007
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, 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 DURING BIOMED TESTING, THE DEVICE'S DISPLAY WAS FUZZY AND NO CLINICAL INFORMATION COULD BE SEEN. COMPLAINANT INDICATED THAT THERE WAS NO PT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 281059 | E SERIES DEFIBRILLATOR | E SERIES | MKJ | ZOLL MEDICAL CORP | E SERIES | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |