FDA Adverse Event
Malfunction
Summary report: N
PEDI PADZ II PEDIATRIC MULTI-FUNCTION ELECTRODES
MDR report key: 4670913
·
Received April 2, 2015
Report
- Report Number
- 1218058-2015-00002
- Event Type
- Malfunction
- Date Received
- April 2, 2015
- Report Date
- March 16, 2015
- Manufacturer
- BIO-DETEK, INC.
- Product Code
- MKJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE ELECTRODES WERE RETURNED FOR EVALUATION AND THE CUSTOMER'S REPORT WAS NOT REPLICATED OR CONFIRMED A THOROUGH EVALUATION OF THE ELECTRODES WAS PERFORMED AND NO ASSEMBLY OR PERFORMANCE ISSUES WERE FOUND. BASED ON THE RESULTS, IT WAS CONCLUDED THERE WERE NO DISCREPANCIES WITH THIS SAMPLE ELECTRODES. NO TREND IS ASSOCIATED WITH REPORTS OF THIS TYPE.
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 DURING FUNCTIONAL TESTING, THE PEDIATRIC PADS WERE RECOGNIZED AS ADULT PADS. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 219075 | PEDI PADZ II PEDIATRIC MULTI-FUNCTION ELECTRODES | ELECTRODE | MKJ | BIO-DETEK, INC. | 8900-0810 | 1514 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |