FDA Adverse Event
Malfunction
Summary report: N
PIC30
MDR report key: 2659845
·
Received July 11, 2012
Report
- Report Number
- 3023750-2012-01029
- Event Type
- Malfunction
- Date Received
- July 11, 2012
- Report Date
- April 9, 2012
- Manufacturer
- WELCH ALLYN PROTOCOL, INC.
- Product Code
- MKJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TW
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THIS MEDWATCH REPORT IS A CORRECTION TO A PREVIOUS INITIAL MEDWATCH REPORT SUBMITTED. PLEASE REFERENCE MEDWATCH REPORT 1220980-2012-00983, WHICH WAS SENT ON 4/26/2012 WITH AN INCORRECT REGISTRATION NUMBER. EVAL: THE MALFUNCTION WAS DUPLICATED AND ATTRIBUTED TO A FAULTY FUSE ON THE DEFIBRILLATOR BOARD. ANALYSIS FOR REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND.
Description of Event or Problem · 1
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE DISPLAYED A "DEFIB FAULT 11" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PIC30 | AUTOMATED EXTERNAL DEFIB | MKJ | WELCH ALLYN PROTOCOL, INC. | PIC30 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |