FDA Adverse Event
Malfunction
Summary report: N
N595 PULSE OXIMETER
MDR report key: 1002149
·
Received February 25, 2008
Report
- Report Number
- 2936999-2008-00093
- Event Type
- Malfunction
- Date Received
- February 25, 2008
- Date of Event
- February 1, 2008
- Report Date
- February 25, 2008
- Manufacturer
- FORMERLY NELLCOR PURITAN BENNETT
- Product Code
- DQA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE CALLER HAS DECLINED RETURNING THE DEVICE FOR EVAL. THE CALLER REPORTED THAT THE PROBLEM WAS ISOLATED TO THE MAIN PCB AND WOULD LIKE TO ORDER A REPLACEMENT PART FOR IN HOUSE REPAIR. MFG FACILITY HAS INITIATED A CORRECTIVE AND PREVENTATIVE ACTION ASSOCIATED WITH THE CUSTOMER REPORTED FAILURE. THE CAPA REFERENCED IN THIS REPORT WAS AN INTERNAL INVESTIGATION, NOT A FIELD ACTION; THEREFORE IT IS NOT REQUIRED TO NOTIFY THE FDA DISTRICT OFFICE. IF THE DEVICE IS RETURNED FOR INVESTIGATION, RESULTS OF THE INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
NELLCOR PURITAN BENNETT RECEIVED A REPORT FROM A BIOMEDICAL ENGINEER THAT THE UNIT DID NOT PROVIDE AN AUDIO TONE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | N595 PULSE OXIMETER | PULSE OXIMETER | DQA | FORMERLY NELLCOR PURITAN BENNETT | N595 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |