FDA Adverse Event
Death
Summary report: N
AED 20
MDR report key: 1581737
·
Received January 13, 2010
Report
- Report Number
- 3023750-2010-01010
- Event Type
- Death
- Date Received
- January 13, 2010
- Date of Event
- November 24, 2009
- Report Date
- December 9, 2009
- Manufacturer
- WELCH ALLYN PROTOCOL, INC.
- Product Code
- MKJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT HAS BEEN RECEIVED, AND A FOLLOW-UP REPORT WILL BE PROVIDED WHEN OUR INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT, THE DEVICE FAILED TO DISCHARGE. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AED 20 | AUTOMATED EXTERNAL DEFIB | MKJ | WELCH ALLYN PROTOCOL, INC. | AED20 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Death |