FDA Adverse Event
Malfunction
Summary report: N
X SERIES
MDR report key: 3181766
·
Received June 6, 2013
Report
- Report Number
- 1220908-2013-01379
- Event Type
- Malfunction
- Date Received
- June 6, 2013
- Date of Event
- May 6, 2013
- Report Date
- May 17, 2013
- Manufacturer
- ZOLL MEDICAL CORPORATION
- Product Code
- MKJ
- PMA / PMN Number
- K112432
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ZOLL MEDICAL CORPORATION HAS RECEIVED THE PRODUCT AND WILL BE PROVIDING A F/U REPORT WHEN OUR INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
COMPLAINANT ALLEGED THAT DURING A RESCUE HELICOPTER TRANSFER OF A (B)(6) MALE PT WITH MYOCARDIAL INFARCTION, THE DEVICE WAS POWERED OFF AND THEN POWERED BACK ON AFTER APPROX FIVE SECONDS. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PT DUE TO THE REPORTED MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 252208 | X SERIES | DEFIBRILLATOR/PACEMAKER | MKJ | ZOLL MEDICAL CORPORATION | X SERIES | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR |