FDA Adverse Event
Malfunction
Summary report: N
X SERIES
MDR report key: 5798354
·
Received July 15, 2016
Report
- Report Number
- 1220908-2016-01651
- Event Type
- Malfunction
- Date Received
- July 15, 2016
- Report Date
- June 27, 2016
- Manufacturer
- ZOLL MEDICAL CORPORATION
- Product Code
- MKJ
- PMA / PMN Number
- K112432
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ZOLL MEDICAL CORPORATION EVALUATED THE DEVICE AND THE REPORTED MALFUNCTION WAS OBSERVED AND ATTRIBUTED TO A DEFIB MONITOR FLEX CABLE THAT WAS NOT PROPERLY SEATED. THE DEVICE'S FLEX CABLE WAS REPLACED TO RESOLVE THE MALFUNCTION. NO TREND IS ASSOCIATED WITH REPORTS OF THIS TYPE.
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 BIOMED TESTING, THE DEVICE FAILED SELF TEST. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 451019 | X SERIES | DEFIBRILLATOR/PACEMAKER | MKJ | ZOLL MEDICAL CORPORATION | X SERIES | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |