FDA Adverse Event
Malfunction
Summary report: N
RADIUS-7 WI-FI KIT
MDR report key: 13006469
·
Received December 14, 2021
Report
- Report Number
- 3019388613-2021-00348
- Event Type
- Malfunction
- Date Received
- December 14, 2021
- Date of Event
- November 1, 2021
- Report Date
- November 19, 2021
- Manufacturer
- MASIMO - 15750 ALTON PKWY
- Product Code
- DQA
- UDI-DI
- 00843997014106
- PMA / PMN Number
- K183697
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
ATTEMPTS HAVE BEEN MADE TO OBTAIN THE PRODUCT. THE PRODUCT HAS NOT BEEN RETURNED TO MASIMO TO ALLOW AN ANALYSIS TO BE PERFORMED. IF THE PRODUCT IS RETURNED FOR EVALUATION OR NEW INFORMATION IS OBTAINED, A FOLLOW UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 0
THE CUSTOMER REPORTED INTERMITTENT CONNECTION. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Description of Event or Problem · 0
THE CUSTOMER REPORTED INTERMITTENT CONNECTION. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1896256 | RADIUS-7 WI-FI KIT | OXIMETER | DQA | MASIMO - 15750 ALTON PKWY | 26823 | 00843997014106 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |