FDA Adverse Event
Malfunction
Summary report: N
RAD-8 HORIZ MS-2000
MDR report key: 4254186
·
Received November 7, 2014
Report
- Report Number
- 2031172-2014-00391
- Event Type
- Malfunction
- Date Received
- November 7, 2014
- Date of Event
- October 8, 2014
- Report Date
- October 9, 2014
- Manufacturer
- MASIMO CORPORATION
- Product Code
- DQA
- PMA / PMN Number
- K092838
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS BEEN RETURNED TO MASIMO FOR EVAL. WHEN THE INVESTIGATION IS COMPLETE, A F/U REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WILL NOT HOLD A CHARGE FOR MORE THAN 45 MINUTES DURING THE FIRST TRANSPORT (PER THE PT'S DAD). ALSO, THE PR AND SPO2 ACCURACY IS NOT GOOD. THE LNC-10 AND LNC NEO ARE USED BY THE PT. NO PT INCIDENT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 718719 | RAD-8 HORIZ MS-2000 | OXIMETER | DQA | MASIMO CORPORATION | 22042 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |