FDA Adverse Event
Malfunction
Summary report: N
E SERIES DEFIBRILLATOR
MDR report key: 4232329
·
Received October 23, 2014
Report
- Report Number
- 1220908-2014-02730
- Event Type
- Malfunction
- Date Received
- October 23, 2014
- Report Date
- October 8, 2014
- Manufacturer
- ZOLL MEDICAL CORPORATION
- Product Code
- MKJ
- PMA / PMN Number
- K042007
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RETURNED TO ZOLL MEDICAL (B)(4); THE MALFUNCTION WAS DUPLICATED AND ATTRIBUTED TO A FAULTY BATTERY INTERCONNECT TO SYSTEM CABLE. THE CABLE WAS REPLACED TO RESOLVE THE MALFUNCTION AND THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER.
Description of Event or Problem · 1
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE DISPLAYED "DEFIB DISABLED", "PACER DISABLED" AND "DEFIB FAULT 72" MESSAGES. THE COMPLAINANT ALSO STATED THE DEVICE WOULD NOT RECOGNIZE PADS OR PADDLES. COMPLAINANT INDICATED THAT THERE WAS NO PT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 674404 | E SERIES DEFIBRILLATOR | E SERIES | MKJ | ZOLL MEDICAL CORPORATION | E SERIES | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |