FDA Adverse Event
Malfunction
Summary report: N
X SERIES
MDR report key: 4842094
·
Received June 9, 2015
Report
- Report Number
- 1220908-2015-01426
- Event Type
- Malfunction
- Date Received
- June 9, 2015
- Report Date
- May 21, 2015
- Manufacturer
- ZOLL MEDICAL CORPORATION
- Product Code
- MKJ
- PMA / PMN Number
- K112432
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RETURNED TO ZOLL MEDICAL CORP. DURING EVALUATION OF THE DEVICE TO DETERMINE ROOT CAUSE. THE TECH OBSERVED EXTENSIVE DAMAGE. THE OBSERVED DAMAGE IS TYPICALLY A RESULT OF THE DEVICE BEING TAMPERED WITH. ROOT CAUSE COULD NOT BE FIRMLY ESTABLISHED DUE TO THE OBSERVED DAMAGE. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.
Description of Event or Problem · 1
COMPLAINANT ALLEGED THAT DURING A STAFF TRAINING SESSION, THE DEVICE INAPPROPRIATELY SHUT DOWN. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 371837 | X SERIES | DEFIBRILLATOR/ PACEMAKER | MKJ | ZOLL MEDICAL CORPORATION | X SERIES | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |