FDA Adverse Event
Other
Summary report: N
INVIVO CORPORATION
MDR report key: 1692185
·
Received May 12, 2010
Report
- Report Number
- 1051786-2010-00015
- Event Type
- Other
- Date Received
- May 12, 2010
- Report Date
- April 16, 2010
- Manufacturer
- INVIVO CORPORATION
- Product Code
- DQA
- PMA / PMN Number
- K864730
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE CUSTOMER REPORTED THAT THE DEVICE WAS NOT RECEIVING AUDIO ALARMS. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFO REGARDING THIS INCIDENT AND THE COMPLAINT REMAINS UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED. (B)(4).
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT A PT CODE OCCURRED BUT THE DEVICE WAS NOT RECEIVING AUDIO ALARMS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INVIVO CORPORATION | INVIVO PULSE OXIMETER, MODEL 4500 | DQA | INVIVO CORPORATION | 4500 PLUS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |