FDA Adverse Event
Injury
Summary report: N
ACUITY CENTRAL MONITORING
MDR report key: 2062595
·
Received April 8, 2011
Report
- Report Number
- 3023750-2011-00028
- Event Type
- Injury
- Date Received
- April 8, 2011
- Date of Event
- March 9, 2011
- Report Date
- March 11, 2011
- Manufacturer
- WELCH ALLYN PROTOCOL, INC.
- Product Code
- DSI
- PMA / PMN Number
- K052160
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE EVAL IS NOT YET COMPLETE. A F/U REPORT WILL BE SUBMITTED WHEN THE EVAL IS FINISHED. IN THE MEANTIME, WE ARE REPORTING IN AN ABUNDANCE OF CAUTION.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THEY HAD A PT DROP OUT. THE PT HAD BEEN ON THE 11TH FLOOR SYSTEM AND WAS BEING TRANSFERRED TO (B)(6). WHILE BEING TRANSPORTED, THE PT DROPPED OUT; THE NURSING STAFF REPORTED THAT THE WAVEFORMS WERE STILL ON THE MICROPAQ DEVICE. DURING THE DROP OUT, THE PT WENT INTO A CODE BLUE. THE NURSING STAFF WAS WITH THE PT, AS THEY WERE TRANSFERRING THEM, SO THEY WERE ABLE TO QUICKLY RESPOND. THE PT WAS ULTIMATELY DISCHARGED.
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 | Other |