FDA Adverse Event
Death
Summary report: N
STAT*PADZ II ADULT MULTI-FUNCTION ELECTRODES
MDR report key: 6165718
·
Received December 12, 2016
Report
- Report Number
- 1218058-2016-00153
- Event Type
- Death
- Date Received
- December 12, 2016
- Date of Event
- November 23, 2016
- Report Date
- November 23, 2016
- Manufacturer
- BIO-DETEK INCORPORATED
- Product Code
- MKJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE DEVICE FOR EVALUATION AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.
Additional Manufacturer Narrative · 1
THE COMPLAINANT WAS CONTACTED FOR RETURN OF THE DEVICE. THE DEVICE HAS NOT BEEN RETURNED TO ZOLL FOR EVALUATION.
Description of Event or Problem · 1
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A (B)(6) MALE PATIENT, THE DEVICE WAS UNABLE TO OBTAIN AN ECG SIGNAL VIA ELECTRODE PADS. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER SET OF ELECTRODE PADS TO CONTINUE TREATING THE PATIENT. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 818295 | STAT*PADZ II ADULT MULTI-FUNCTION ELECTRODES | DEFIB/PACING ELECTRODES | MKJ | BIO-DETEK INCORPORATED | 8900-0801-01 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Death |