FDA Adverse Event
Malfunction
Summary report: N
TERUMO CDI 100 MONITOR
MDR report key: 1834550
·
Received September 9, 2010
Report
- Report Number
- 1828100-2010-01376
- 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
- DTY
- PMA / PMN Number
- K902654
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
EVAL IN PROGRESS, BUT NOT YET CONCLUDED.
Description of Event or Problem · 1
DURING ROUTINE TESTING OF THE DEVICE AT THE SERVICE CENTER, THE SERVICE TECHNICIAN REPORTED THE BOTTOM PORTION OF THE BATTERY PACK WAS CRACKED. THE MONITOR WAS ORIGINALLY RETURNED FOR REPAIR DUE TO AN ERROR MESSAGE DISPLAYED WHEN THE CRACKED BATTERY PACK 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 100 MONITOR | MONITOR | DTY | TERUMO CARDIOVASCULAR SYSTEMS CORP | 100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |