FDA Adverse Event
Malfunction
Summary report: N
PROPAQ CS 246
MDR report key: 2151374
·
Received June 8, 2011
Report
- Report Number
- 3023750-2011-00048
- Event Type
- Malfunction
- Date Received
- June 8, 2011
- Date of Event
- May 9, 2011
- Report Date
- May 9, 2011
- Manufacturer
- WELCH ALLYN PROTOCOL, INC.
- Product Code
- DRT
- PMA / PMN Number
- K012451
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE EVALUATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.
Description of Event or Problem · 1
WELCH ALLYN RECEIVED A COMPLAINT WHERE A PROPAQ CS BEDSIDE MONITOR'S DISPLAY LOCKED-UP WHILE MONITORING A PT. THE COMPLAINANT ALSO INDICATED THAT THE PROPAQ CS MONITOR DID NOT PROVIDE THE CLINICIAN ANY AUDIBLE OR VISUAL ALARMS. THERE WAS NO REPORT OF ANY PT HARM AS A RESULT OF THE REPORTED EVENT. NOTE: THE CUSTOMER DID NOT PROVIDE ANY PT INFO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROPAQ CS 246 | DRT | WELCH ALLYN PROTOCOL, INC. | PROPAQ 246 CS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |