FDA Adverse Event
Malfunction
Summary report: N
M SERIES
MDR report key: 4961021
·
Received July 27, 2015
Report
- Report Number
- 1220908-2015-01877
- Event Type
- Malfunction
- Date Received
- July 27, 2015
- Report Date
- July 7, 2015
- Manufacturer
- ZOLL MEDICAL CORPORATION
- Product Code
- MKJ
- PMA / PMN Number
- K990762
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE PRODUCT FOR EVALUATION AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.
Additional Manufacturer Narrative · 1
THE CUSTOMER WAS CONTACTED FOR RETURN OF THE SUSPECT PRODUCT. THE CUSTOMER HAS RESPONDED AND INDICATED THE PRODUCT WILL NOT BE RETURNING TO ZOLL.
Description of Event or Problem · 1
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE WAS UNABLE TO SWITCH OUT OF CONFIGURATION MODE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 487699 | M SERIES | DEFIBRILLATOR/PACEMAKER | MKJ | ZOLL MEDICAL CORPORATION | M SERIES BI-PHASIC | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |