FDA Adverse Event
Malfunction
Summary report: N
TEMPERATURE ADAPTER CABLE ASSEMBLY
MDR report key: 1073714
·
Received July 1, 2008
Report
- Report Number
- 3023361-2008-00018
- Event Type
- Malfunction
- Date Received
- July 1, 2008
- Date of Event
- September 27, 2007
- Report Date
- July 1, 2008
- Manufacturer
- SPACELABS HEALTHCARE
- Product Code
- MHX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TC
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
SPACELABS PERFORMED A HEALTH HAZARD EVALUATION IN 2007, WHICH IDENTIFIED THAT MITIGATION IS REQUIRED TO PREVENT POSSIBLY DELAY IN PT CARE. REVIEW OF OUR POST MARKET SURVEILLANCE HAS REVEALED THAT SPACELABS HAD NOT PREVIOUSLY SUBMITTED A REPORT OF THIS ISSUE TO THE FDA. WE ARE NOW REPORTING THIS ISSUE AS REQUIRED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT A TOTAL OF THREE TEMPERATURE ADAPTER CABLES PART NUMBER 700-0031-00 WERE CAUSING INTERMITTENT DROPOUTS OR NOT SIGNING ON. IT WAS REPORTED THAT IN THIS FAILURE MODE, THE TEMPERATURE VALUE COULD NOT BE VIEWED ON THE MONITOR. NO INJURIES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TEMPERATURE ADAPTER CABLE ASSEMBLY | NONE | MHX | SPACELABS HEALTHCARE | OSC 03/07 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |