FDA Adverse Event
Malfunction
Summary report: N
PIC
MDR report key: 1070695
·
Received July 2, 2008
Report
- Report Number
- 3023750-2008-00162
- Event Type
- Malfunction
- Date Received
- July 2, 2008
- Date of Event
- June 12, 2008
- Report Date
- June 12, 2008
- Manufacturer
- WELCH ALLYN PROTOCOL, INC.
- Product Code
- MKJ
- PMA / PMN Number
- K012766
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
MANUFACTURER'S EVALUATION SUMMARY: THE DEVICE IS AN AUTOMATIC EXTERNAL DEFIBRILLATOR AND THE ACTUAL DEVICE INVOLVED WAS EVALUATED. THE INVESTIGATION CONFIRMED THE REPORTED PROBLEM. TROUBLESHOOTING ISOLATED THE CAUSE OF THE FAILURE TO THE DISPLAY. REPLACEMENT OF THE DISPLAY RESOLVED THE ISSUE. THE REPAIRED DEVICE WAS RETURNED TO THE CUSTOMER AFTER PASSING ACCEPTANCE TESTING.
Description of Event or Problem · 1
A WELCH ALLYN SALES REP INDICATED THAT THEIR DEMO UNIT HAS LINES IN THE DISPLAY. NO PT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PIC | MKJ | WELCH ALLYN PROTOCOL, INC. | PIC 50 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |