FDA Adverse Event
Malfunction
Summary report: N
NELLCOR
MDR report key: 7001901
·
Received November 3, 2017
Report
- Report Number
- 2936999-2017-05595
- Event Type
- Malfunction
- Date Received
- November 3, 2017
- Date of Event
- October 2, 2017
- Report Date
- November 3, 2017
- Manufacturer
- MEDIANA CO. LTD.
- Product Code
- DQA
- PMA / PMN Number
- K141542
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- 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. THE CUSTOMER INDICATE THERE WAS NO PATIENT INJURY ASSOCIATE WITH THIS EVENT. MEDTRONIC IS REQUESTING ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES OF THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 779703 | NELLCOR | OXIMETER | DQA | MEDIANA CO. LTD. | PM10N | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |