FDA Adverse Event
Malfunction
Summary report: N
X SERIES
MDR report key: 3850335
·
Received March 17, 2014
Report
- Report Number
- 1220908-2014-00614
- Event Type
- Malfunction
- Date Received
- March 17, 2014
- Date of Event
- February 24, 2014
- Report Date
- February 26, 2014
- Manufacturer
- ZOLL MEDICAL CORPORATION,
- Product Code
- MKJ
- PMA / PMN Number
- K112432
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- 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 WHILE ATTEMPTING TO MONITOR A PT CIA LEADS (AGE AND GENDER UNK) THE DEVICE DISPLAYED A "SYSTEM SHUTDOWN INTERNAL ERROR OCCURRED SYSTEM RESET REQUIRED" MESSAGE. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE TO CONTINUE TREATING THE PT. 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 |
|---|---|---|---|---|---|---|---|
| 157362 | X SERIES | DEFIBRILLATOR/PACEMAKER | MKJ | ZOLL MEDICAL CORPORATION, | X SERIES | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |