FDA Adverse Event
Malfunction
Summary report: N
SPACELABS MEDICAL PATIENT MONITOR
MDR report key: 2010149
·
Received February 11, 2011
Report
- Report Number
- 3023361-2011-00002
- Event Type
- Malfunction
- Date Received
- February 11, 2011
- Date of Event
- January 8, 2011
- Report Date
- February 9, 2011
- Manufacturer
- SPACELABS HEALTHCARE
- Product Code
- MHX
- PMA / PMN Number
- K102422
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
SPACELABS IS WORKING WITH THE CUSTOMER TO COORDINATE TESTING THE DEVICE AND HAS REQUESTED THAT THE SUSPECT DEVICE BE RETURNED TO OUR FACILITY FOR A DETAILED EVALUATION, WE ARE WAITING TO RECEIVE THE DEVICE. NO ONE HAS BEEN INJURED AS A RESULT OF THIS ALLEGED MALFUNCTION. WE WILL PROVIDE A SUPPLEMENTAL REPORT ONCE OUR INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
SPACELABS RECEIVED A REPORT THAT ALLEGES THAT A TELEMETRY CENTRAL STATION, IN ICU, FAILED TO ALARM FOR AN ASYSTOLE CONDITION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPACELABS MEDICAL PATIENT MONITOR | TELEMETRY CENTRAL STATION | MHX | SPACELABS HEALTHCARE | 91387 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | MODEL 90478| SPACELABS DIGITAL TELEMETRY RECEIVER MODULE, |