FDA Adverse Event
Malfunction
Summary report: N
E SERIES DEFIBRILLATOR
MDR report key: 2915800
·
Received December 5, 2012
Report
- Report Number
- 1220908-2012-03308
- Event Type
- Malfunction
- Date Received
- December 5, 2012
- Date of Event
- November 20, 2012
- Report Date
- November 20, 2012
- Manufacturer
- ZOLL MEDICAL CORPORATION
- Product Code
- MKJ
- PMA / PMN Number
- K042007
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- PARAMEDIC
Narratives
Additional Manufacturer Narrative · 1
ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE PRODUCT FOR EVAL AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.
Description of Event or Problem · 1
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO MONITOR THE HEART RHYTHM OF A (B)(6), MALE PT, THE DEVICE POWERED ON WITHOUT DISPLAY. COMPLAINANT INDICATED THAT THERE WAS NO 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 MEDICAL CORPORATION | E SERIES | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR |