FDA Adverse Event
Malfunction
Summary report: N
TERUMO CDI 500 BLOOD PARAMETER MONITOR
MDR report key: 1834540
·
Received September 9, 2010
Report
- Report Number
- 1828100-2010-01361
- Event Type
- Malfunction
- Date Received
- September 9, 2010
- Date of Event
- August 18, 2010
- Report Date
- September 9, 2010
- Manufacturer
- TERUMO CARDIOVASCULAR SYSTEMS CORP
- Product Code
- DRY
- PMA / PMN Number
- K972962
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
EVALUATION IN PROGRESS, BUT NOT YET CONCLUDED.
Description of Event or Problem · 1
DURING ROUTINE TESTING OF THE DEVICE AT THE SERVICE CENTER, THE SERVICE TECH REPORTED, THE BATTERY CONNECTOR WAS CRACKED. THE MONITOR WAS ORIGINALLY RETURNED FOR REPAIR OF AN "F0A1" INITIALIZATION FAILURE WHEN THE CRACKED BATTERY CONNECTOR WAS FOUND. SINCE THIS EVENT OCCURRED AT THE SERVICE CENTER, THERE WAS NO PT INVOLVEMENT DURING THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TERUMO CDI 500 BLOOD PARAMETER MONITOR | ON LINE BLOOD GAS MONITOR | DRY | TERUMO CARDIOVASCULAR SYSTEMS CORP | 500AHCT |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |