RAD-57 PULSE CO-OXIMETER
Report
- Report Number
- 3019388613-2023-00186
- Event Type
- Malfunction
- Date Received
- July 26, 2023
- Date of Event
- June 26, 2023
- Report Date
- July 3, 2023
- Manufacturer
- MASIMO - 15750 ALTON PKWY
- Product Code
- DQA
- UDI-DI
- 00843997006163
- PMA / PMN Number
- K053477
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
ADDITIONAL MANUFACURING NARRATIVE: 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.
ADDITIONAL MANUFACTURING NARRATIVE: THE RETURNED DEVICE WAS EVALUATED. DURING EVALUATION THE DEVICE PASSED ALL VISUAL AND FUNCTIONAL TESTING. DURING SIMULATION TESTING, THE DEVICE PASSED MANUAL AND PRESET CONDITIONS AND PROVIDED ACCURATE MEASUREMENTS. THE UNIT WAS FOUND TO VISUALLY AND AUDIBLY ALARM DURING ALARM CONDITIONS. THE UNIT WAS DETERMINED TO BE FUNCTIONING AS DESIGNED., OTHER, OTHER TEXT: THE CUSTOMER MX-51 BOARD DID NOT HAVE THE SPMET PARAMETER ENABLED AND SPMET MEASUREMENTS COULD NOT BE OBTAINED. G.5. 510K WAS LISTED AS:K080238; IS K053477.
THE CUSTOMER REPORTED THE SPMET VALUES WERE READING HIGHER THAN THEY SHOULD. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
THE CUSTOMER REPORTED THE SPMET VALUES WERE READING HIGHER THAN THEY SHOULD. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1106715 | RAD-57 PULSE CO-OXIMETER | OXIMETER | DQA | MASIMO - 15750 ALTON PKWY | 25195 | 00843997006163 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |