FDA Adverse Event
Malfunction
Summary report: N
AED10
MDR report key: 2063856
·
Received April 12, 2011
Report
- Report Number
- 3023750-2011-01069
- Event Type
- Malfunction
- Date Received
- April 12, 2011
- Report Date
- March 21, 2011
- Manufacturer
- WELCH ALLYN PROTOCOL, INC.
- Product Code
- MKJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- 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 DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE PROMPTED A "DO NOT USE" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AED10 | AUTOMATED EXTERNAL DEFIB | MKJ | WELCH ALLYN PROTOCOL, INC. | AED10 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |