FDA Adverse Event
Death
Summary report: N
PIC 50
MDR report key: 1575132
·
Received January 7, 2010
Report
- Report Number
- 3023750-2010-01004
- Event Type
- Death
- Date Received
- January 7, 2010
- Date of Event
- August 1, 2009
- Report Date
- January 7, 2010
- Manufacturer
- WELCH ALLYN PROTOCOL, INC
- Product Code
- MKJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS EVALUATED AND THE REPORTED MALFUNCTION WAS NOT REPLICATED OR CONFIRMED. THE DEVICE WAS PUT THROUGH EXTENSIVE TESTING, WHICH INCLUDED ENVIRONMENTAL AND FUNCTIONAL TESTING WITHOUT DUPLICATING THE MALFUNCTION. THE DEVICE WAS RECERTIFIED AND RETURNED TO THE CUSTOMER. NO TREND IS ASSOCIATED WITH REPORTS OF THIS TYPE.
Description of Event or Problem · 1
COMPLAINANT ALLEGED THAT DURING A ECG ANALYSIS ON A FEMALE PT, THE DEVICE'S ECG RHYTHM DISPLAYED BY THE DEVICE WAS VERY NOISY AND UNREADABLE. COMPLAINANT INDICATED THAT THE PT SUFFERED CARDIAC ARREST WHILE WAITING FOR PREPARATION OF OBTAINING ANOTHER DEVICE. COMPLAINANT INDICATED THAT THE PT SUBSEQUENTLY EXPIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PIC 50 | AUTOMATED EXTERNAL DEFIB | MKJ | WELCH ALLYN PROTOCOL, INC | PIC50 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 12 YR | Death |