FDA Adverse Event
Malfunction
Summary report: N
STAT PADZ ELECTRODES
MDR report key: 2943462
·
Received January 8, 2013
Report
- Report Number
- 1220908-2012-03591
- Event Type
- Malfunction
- Date Received
- January 8, 2013
- Report Date
- December 18, 2012
- Manufacturer
- ZOLL MEDICAL CORPORATION
- Product Code
- MLN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE PRODUCT FOR EVALUATION AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.
Description of Event or Problem · 1
COMPLAINANT ALLEGED THAT WHILE DEFIBRILLATING A PATIENT (AGE AND GENDER UNKNOWN), THE DEFIB ELECTRODE PADS WERE ATTACHED TO AN ASSOCIATED DEFIBRILLATOR. UPON DISCHARGE, A SMALL SPARK WAS SEEN UNDERNEATH THE ANTERIOR ELECTRODE PAD. THE PADS WERE REMOVED AND RE-APPLIED TO THE PATIENT TO CONTINUE TREATMENT. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 10389 | STAT PADZ ELECTRODES | ELECTRODE | MLN | ZOLL MEDICAL CORPORATION | 8900-4003 | 3712 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |