FDA Adverse Event
Malfunction
Summary report: N
ACUITY CENTRAL MONITORING
MDR report key: 3023102
·
Received February 27, 2013
Report
- Report Number
- 3023750-2013-00026
- Event Type
- Malfunction
- Date Received
- February 27, 2013
- Date of Event
- February 1, 2013
- Report Date
- February 1, 2013
- Manufacturer
- WELCH ALLYN PROTOCOL, INC.
- Product Code
- DSI
- PMA / PMN Number
- K052160
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
THE BMET CONFIRMED THA THE CPU SPEAKER FAILED. THE CPU WILL NOT BE RETURNED FOR EVALUATION. THE ACUITY CPU SPEAKER IS AN OFF-THE-SHELF COMPUTER SUB-COMPONENT MADE BY ANOTHER MFR AND SOLD BY WELCH ALLYN. WELCH ALLYN DOES NOT POSSES TROUBLESHOOTING CAPABILITY BEYOND IDENTIFYING THESE SUB-COMPONENTS AS THE SOURCE OF THE FAILURE. METHOD: BMET CONFIRMED FAILURE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE INTERNAL SPEAKER IN THEIR ACUITY SYSTEM IS NOT WORKING. THE BMET ATTACHED AN EXTERNAL SPEAKER FOR AUDIBLE ALARMS. THERE WAS NO REPORT OF ANY PT HARM AS A RESULT OF THE REPORTED EVENTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 85102 | ACUITY CENTRAL MONITORING | DSI | WELCH ALLYN PROTOCOL, INC. | ACUITY 6.40.01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |