FDA Adverse Event
Malfunction
Summary report: N
OXIMAX N-560 PULSE OXIMETER
MDR report key: 3971152
·
Received April 29, 2014
Report
- Report Number
- 2936999-2014-00381
- Event Type
- Malfunction
- Date Received
- April 29, 2014
- Date of Event
- January 27, 2014
- Report Date
- April 8, 2014
- Manufacturer
- MEDIANA
- Product Code
- DPZ
- PMA / PMN Number
- K012891
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
CUSTOMER REPORTED TO COVIDIEN THAT DURING USE THE MONITOR FROZE, WITH THE VALUE REMAINING DISPLAYED ON IT. CUSTOMER STATED THAT THERE WAS NO ALARM GENERATED AT THE INCIDENT. A TECHNICIAN NOTICED AND IMMEDIATELY REPLACED THE UNIT TO ANOTHER DEVICE. NO PATIENT HARM WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 256612 | OXIMAX N-560 PULSE OXIMETER | PULSE OXIMETER | DPZ | MEDIANA | N-560 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |