FDA Adverse Event
Malfunction
Summary report: N
UVSL COMMAND MODULE
MDR report key: 1172725
·
Received September 22, 2008
Report
- Report Number
- 3023361-2008-00058
- Event Type
- Malfunction
- Date Received
- September 22, 2008
- Date of Event
- August 15, 2008
- Report Date
- September 22, 2008
- Manufacturer
- SPACELABS HEALTHCARE
- Product Code
- MHX
- PMA / PMN Number
- K972502
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
SPACELABS TESTED THE UNIT AND DETERMINED AN INTEGRATED CIRCUIT HAD FAILED. THE SYSTEM PERFORMED TO SPECIFICATION AFTER THE INTEGRATED CIRCUIT WAS REPLACED. THE INTEGRATED CIRCUIT HAS BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS. SPACELABS IS CONTINUING ITS INVESTIGATION INTO THIS ISSUE AND WILL SUPPLEMENT THIS MDR AS APPROPRIATE.
Description of Event or Problem · 1
THE HOSPITAL REPORTED THAT, DURING TESTING, THE COMMAND MODULE DID NOT PROVIDE AN APPROPRIATE ECG OUTPUT SIGNAL TO AN EXTERNAL DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UVSL COMMAND MODULE | NONE | MHX | SPACELABS HEALTHCARE | 91496-1BGMR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |