FDA Adverse Event
Other
Summary report: N
RESPIRONICS
MDR report key: 1523795
·
Received November 6, 2009
Report
- Report Number
- 2183646-2009-00007
- Event Type
- Other
- Date Received
- November 6, 2009
- Report Date
- November 4, 2009
- Manufacturer
- NONIN MEDICAL, INC.
- Product Code
- DQA
- PMA / PMN Number
- K002690
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
INITIAL DEVICE EVAL SHOWS NO SIGNS OF THERMAL DAMAGE ON THE OXIMETER OR SENSOR. OXIMETER AND SENSOR PASSED FUNCTIONAL TESTING WITH NO SIGN OF SHORTING. FULL ELECTRICAL TESTING WILL BE COMPLETED, IF ANY PROBLEMS ARE IDENTIFIED, A FOLLOW UP REPORT WILL BE COMPLETED.
Description of Event or Problem · 1
PT STATES THE UNIT BLOW UP WITH SPARKS. PT BROUGHT THE UNIT BACK IN, AND A RESPIRATORY THERAPIST DID TAKE IT HOME AND TESTED IT AND IT WORKED FINE. ADDITIONAL STATEMENT THAT PT WAS WEARING THE UNIT DURING THE NIGHT AND FELT A SHOCK, NOT SURE IF IT WAS THE BLANKET OR THE UNIT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESPIRONICS | MODEL 920MP OXIMETER AND 8000AA SENSOR | DQA | NONIN MEDICAL, INC. | 920MP | 8000A - 119710583 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR | Other |