FDA Adverse Event
Malfunction
Summary report: N
TRANSTAR PATIENT MOUNT MONITORING KIT
MDR report key: 1181942
·
Received September 26, 2008
Report
- Report Number
- 9616567-2008-00079
- Event Type
- Malfunction
- Date Received
- September 26, 2008
- Date of Event
- August 27, 2008
- Report Date
- August 27, 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
SAMPLES HAVE BEEN RECEIVED FROM THE CUSTOMER; HOWEVER, SMITHS HAS NOT YET COMPLETED ITS INVESTIGATION. A FOLLOW UP MDR WILL BE SUBMITTED WHEN THE INVESTIGATION HAS BEEN COMPLETED.
Description of Event or Problem · 1
A HEALTH CENTER REPORTED TO SMITHS MEDICAL THAT THE EQUIPMENT CAME APART AT THE LUER LOCK DESPITE HAVING SECURELY FASTENED IT EARLIER IN THE SHIFT. THERE WAS NO PT INJURY OR TREATMENT REPORTED 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 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |