FDA Adverse Event
Death
Summary report: N
PIC 50
MDR report key: 1373753
·
Received April 30, 2009
Report
- Report Number
- 3023750-2009-00102
- Event Type
- Death
- Date Received
- April 30, 2009
- Report Date
- April 20, 2009
- Manufacturer
- WELCH ALLYN PROTOCOL, INC.
- Product Code
- MKJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RECEIVED FOR EVALUATION, AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.
Description of Event or Problem · 1
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO MONITOR A MALE PATIENT, THE DEVICE INAPPROPRIATELY SHUT DOWN. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE TO CONTINUE TREATING THE PATIENT. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PIC 50 | AUTOMATED EXTERNAL DEFIB | MKJ | WELCH ALLYN PROTOCOL, INC. | PIC50 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Death |