FDA Adverse Event
Death
Summary report: N
AED 10
MDR report key: 1642103
·
Received March 23, 2010
Report
- Report Number
- 3023750-2010-01057
- Event Type
- Death
- Date Received
- March 23, 2010
- Date of Event
- February 7, 2010
- Report Date
- March 5, 2010
- 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 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 DEFIBRILLATE A MALE PATIENT WHO WAS IN CARDIAC ARREST, THE DEVICE INAPPROPRIATELY SHUT DOWN AND FAILED TO SHOCK THE PATIENT. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE TO CONTINUE TREATING THE PATIENT. COMPLAINANT INDICATED THE PATIENT SUBSEQUENTLY EXPIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AED 10 | AUTOMATED EXTERNAL DEFIB | MKJ | WELCH ALLYN PROTOCOL, INC. | AED10 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Death |