FDA Adverse Event
Malfunction
Summary report: N
NELLCOR
MDR report key: 7130876
·
Received December 19, 2017
Report
- Report Number
- 2936999-2017-05698
- Event Type
- Malfunction
- Date Received
- December 19, 2017
- Date of Event
- October 11, 2017
- Report Date
- December 19, 2017
- Manufacturer
- MEDIANA CO. LTD.
- Product Code
- DQA
- UDI-DI
- 20884521208787
- PMA / PMN Number
- K141542
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
MEDTRONIC RECEIVED A REPORT THE UNIT DID NOT GENERATE AN AUDIBLE ALARM DURING SPO2 DESATURATION. THERE WAS NO PATIENT HARM WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 910718 | NELLCOR | OXIMETER | DQA | MEDIANA CO. LTD. | PM10N | 20884521208787 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |