FDA Adverse Event
Malfunction
Summary report: N
UNIPROBE
MDR report key: 317847
·
Received February 23, 2001
Report
- Report Number
- 8043756-2001-00001
- Event Type
- Malfunction
- Date Received
- February 23, 2001
- Report Date
- February 22, 2001
- Manufacturer
- NELLCOR DE MEXICO, S.A. DE C.V.
- Product Code
- DQA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
ON JANUARY 16, 2001 MALLINCKRODT INC. RECEIVED INFO THAT ALLEGED THAT A UNIPROBE IN CONJUNCTION WITH A MARQUETTE TRAM HAD PROVIDED HIGH SATURATION READINGS. ACCORDING TO THE HOSP THE UNIPROBE WAS PROVIDING SATURATION READINGS OF 100% WHEN THE PT "DIDN'T LOOK RIGHT". REPORTEDLY, WHEN THEY DREW THE ABG THE SATURATION READINGS WERE 89%. NO PT HARM WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 7598 | UNIPROBE | ADAPTER CABLE | DQA | NELLCOR DE MEXICO, S.A. DE C.V. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | MARQUETTE TRAM. |