FDA Adverse Event
Malfunction
Summary report: N
E SERIES DEFIBRILLATOR
MDR report key: 2845003
·
Received October 24, 2012
Report
- Report Number
- 1220908-2012-02857
- Event Type
- Malfunction
- Date Received
- October 24, 2012
- Report Date
- October 9, 2012
- Manufacturer
- ZOLL MED CORP
- Product Code
- MKJ
- PMA / PMN Number
- K042007
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE DEVICE FOR EVAL AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.
Description of Event or Problem · 1
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO MONITOR A PT THE DEVICE'S DISPLAY BECAME DISTORTED AND FROZE SEVERAL TIMES. DURING SUBSEQUENT TESTING, THE DEVICE DID NOT POWER ON. 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 |
|---|---|---|---|---|---|---|---|
| 1 | E SERIES DEFIBRILLATOR | E SERIES | MKJ | ZOLL MED CORP | E SERIES | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |