FDA Adverse Event
Injury
Summary report: N
NASAL ALAR SPO2 SENSOR
MDR report key: 8772671
·
Received July 9, 2019
Report
- Report Number
- 3010150334-2019-00010
- Event Type
- Injury
- Date Received
- July 9, 2019
- Date of Event
- April 30, 2018
- Report Date
- July 9, 2019
- Manufacturer
- XHALE ASSURANCE, INC
- Product Code
- DQA
- PMA / PMN Number
- K171423
- Removal / Correction Number
- 3010150334-50819-001-C
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
FACILITY REPORTED THE SENSOR HAD CAUSED TWO PRESSURE ULCERS. THERE IS NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS REPORT WILL BE UPDATED IF RELEVANT BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 566547 | NASAL ALAR SPO2 SENSOR | OXIMETER, PROBE, SINGLE USE | DQA | XHALE ASSURANCE, INC | 301-11214 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |