FDA Adverse Event
Malfunction
Summary report: N
LOGICAL DOUBLE KIT
MDR report key: 1951273
·
Received December 13, 2010
Report
- Report Number
- 2183502-2010-00576
- Event Type
- Malfunction
- Date Received
- December 13, 2010
- Report Date
- December 7, 2010
- Manufacturer
- SMITHS MEDICAL INTERNATIONAL, LTD.
- Product Code
- DRS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MFR FOR DEVICE EVALUATION. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED, THE MFR WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVAL.
Description of Event or Problem · 1
THE RPTR STATED THAT THE DEVICE TUBING SEPARATED PRIOR TO USE. THERE WAS NO REPORTED PT INJURY OR TREATMENT ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LOGICAL DOUBLE KIT | PRESSURE MONITORING SET | DRS | SMITHS MEDICAL INTERNATIONAL, LTD. | NA | 1817649 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |