FDA Adverse Event
Malfunction
Summary report: N
ACUITY CENTRAL MONITORING
MDR report key: 2050635
·
Received March 14, 2011
Report
- Report Number
- 3023750-2011-00024
- Event Type
- Malfunction
- Date Received
- March 14, 2011
- Date of Event
- February 24, 2011
- Report Date
- February 24, 2011
- Manufacturer
- WELCH ALLYN PROTOCOL, INC.
- Product Code
- DSI
- PMA / PMN Number
- K052160
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE EVAL IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVAL IS FINISHED.
Description of Event or Problem · 1
THE CUSTOMER STATED THAT THE ACUITY CENTRALIZED PT MONITORING SYSTEM EXPERIENCED A DROPOUT OF TWENTY-NINE PATIENTS ON ALL CMR STATIONS. WELCH ALLYN TECHNICAL SUPPORT REMOTELY BOOTED CMR-4 PRIMARY AND PATIENTS RECONNECTED TO ACUITY. THERE WAS NO REPORT OF ANY PT HARM AS A RESULT OF THE REPORTED EVENT. THE CUSTOMER DID NOT PROVIDE ANY PT INFO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACUITY CENTRAL MONITORING | DSI | WELCH ALLYN PROTOCOL, INC. | ACUITY SW 7.10.01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |