FDA Adverse Event
Malfunction
Summary report: N
TRANSTAR PATIENT MOUNT MONITORING KIT
MDR report key: 1003228
·
Received February 21, 2008
Report
- Report Number
- 9616567-2008-00010
- Event Type
- Malfunction
- Date Received
- February 21, 2008
- Report Date
- January 23, 2008
- Manufacturer
- SMITHS MEDICAL, ASD.
- Product Code
- DRS
- PMA / PMN Number
- K942377
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT HAS BEEN RECEIVED FROM THE CUSTOMER; HOWEVER, SMITHS HAS NOT YET COMPLETED ITS INVESTIGATION INTO THIS ISSUE. A FOLLOW UP REPORT WILL BE SUBMITTED AS SOON AS THE INVESTIGATION HAS BEEN COMPLETED.
Description of Event or Problem · 1
A FOREIGN COUNTRY REPORTED TO SMITHS MEDICAL THAT THE TUBING WAS COMING APART. THERE WAS NO PATIENT INJURY OR TREATMENT ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRANSTAR PATIENT MOUNT MONITORING KIT | PRESSURE MONITORING SET | DRS | SMITHS MEDICAL, ASD. | NA | 1225602 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |