FDA Adverse Event
Malfunction
Summary report: N
ACUITY CENTRAL MONITORING
MDR report key: 2143614
·
Received June 3, 2011
Report
- Report Number
- 3023750-2011-00047
- Event Type
- Malfunction
- Date Received
- June 3, 2011
- Date of Event
- May 6, 2011
- Report Date
- May 6, 2011
- Manufacturer
- WELCH ALLYN PROTOCOL, INC.
- Product Code
- DSI
- PMA / PMN Number
- K052160
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, 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 COMPLETE.
Description of Event or Problem · 1
THE CUSTOMER INDICATED THAT ONE OF THEIR ACUITY CENTRAL MONITORING SYSTEM WAS DOWN FOR UNK REASON. THE CUSTOMER THINKS THAT THE HARD DRIVE OF THE CPU IS HAVING PROBLEMS. WELCH ALLYN TECHNICAL SUPPORT ASSISTED THE CUSTOMER BY REMOTELY TROUBLESHOOTING THE ACUITY SYSTEM WITHOUT SUCCESS. THIS RESULTED IN A TEMPORARY LOSS OF CENTRALIZED MONITORING, HOWEVER, BEDSIDE MONITORING WAS NOT AFFECTED. NOTE : 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 S/W 7.02.00 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |