FDA Adverse Event
Malfunction
Summary report: N
SPACELABS ULTRAVIEW PATIENT MONITOR
MDR report key: 3211605
·
Received July 8, 2013
Report
- Report Number
- 3023361-2013-00022
- Event Type
- Malfunction
- Date Received
- July 8, 2013
- Date of Event
- January 10, 2013
- Report Date
- February 12, 2013
- Manufacturer
- SPACELABS MEDICAL INC.
- Product Code
- MHX
- PMA / PMN Number
- K102422
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 1
NO ONE WAS INJURED AS A RESULT OF THIS EVENT. SPACELABS IS EVALUATING THIS EVENT AND WILL FILE A FOLLOW UP REPORT WHEN OUR EVALUATION IS CONCLUDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED A 7 MINUTE RUN OF VFIB WITH NO ALARMS ON THE 91387 PT MONITOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 312127 | SPACELABS ULTRAVIEW PATIENT MONITOR | MHX: MULTIPARAMETER PATIENT MONITOR | MHX | SPACELABS MEDICAL INC. | 91387 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | 91387 (NA)| 91387 (NA) |