FDA Adverse Event
Malfunction
Summary report: N
MARK 5 NUVO 8
MDR report key: 5974030
·
Received September 23, 2016
Report
- Report Number
- 1039215-2016-00002
- Event Type
- Malfunction
- Date Received
- September 23, 2016
- Date of Event
- July 22, 2016
- Report Date
- September 19, 2016
- Manufacturer
- NIDEK MEDICAL PRODUCTS, INC.
- Product Code
- CAW
- PMA / PMN Number
- K093308
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
UPON INSPECTION, IT WAS DETERMINED THE DEVICE WAS DAMAGED DUE TO ABNORMAL USE (I.E. BROKEN REGULATOR).
Description of Event or Problem · 1
"OXYGEN HAD STOPPED FLOWING THROUGH THE CONCENTRATOR. THE CONCENTRATOR DID NOT ALARM TO MAKE THE PATIENT AWARE. THE PATIENT WAS AWARE THAT HE WAS NOT WELL. HIS WIFE REPORTED THAT HE HAD COLD EXTREMITIES, CHEST PAIN AND WAS GREY IN COLOUR. THE MOTOR OF THE CONCENTRATOR WAS STILL RUNNING BUT IT WAS NO ALARMING VISUALLY OR AUDIBLY." (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 624232 | MARK 5 NUVO 8 | OXYGEN CONCENTRATOR | CAW | NIDEK MEDICAL PRODUCTS, INC. | 985UK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | OXYGEN CYLINDER |