FDA Adverse Event
Malfunction
Summary report: N
X SERIES
MDR report key: 3843638
·
Received February 12, 2014
Report
- Report Number
- 1220908-2014-00305
- Event Type
- Malfunction
- Date Received
- February 12, 2014
- Report Date
- January 28, 2014
- Manufacturer
- ZOLL MEDICAL CORPORATION
- Product Code
- MKJ
- PMA / PMN Number
- K112432
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NM, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ZOLL MEDICAL CORPORATION 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 A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE DISPLAYED A "POOR PAD CONTACT" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 93982 | X SERIES | DEFIBRILLATOR/PACEMAKER | MKJ | ZOLL MEDICAL CORPORATION | X SERIES | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |