RAD-97 PULSE CO-OXIMETER WITH NOMOLINE CAPNOGRAPHY
Report
- Report Number
- 3019388613-2023-00278
- Event Type
- Malfunction
- Date Received
- December 12, 2023
- Date of Event
- November 13, 2023
- Report Date
- November 17, 2023
- Manufacturer
- MASIMO - 15750 ALTON PKWY
- Product Code
- MWI
- UDI-DI
- 00843997012782
- PMA / PMN Number
- K212161
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SA
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
ADDITIONAL MANUFACURING NARRATIVE: OTHER, OTHER TEXT: THE DEVICE HAS NOT BEEN RETURNED TO THE INVESTIGATION FACILITY TO ALLOW FOR AN ANALYSIS TO BE PERFORMED. IF THE PRODUCT IS RECEIVED FOR EVALUATION OR NEW INFORMATION IS OBTAINED, A FOLLOW UP REPORT WILL BE SUBMITTED. H3 OTHER TEXT : PRODUCT NOT RETURNED
ADDITIONAL MANUFACTURING NARRATIVE: OTHER, OTHER TEXT: THE RETURNED DEVICE HAD A DEPLETED BATTERY AND WOULD TURN OFF AFTER A FEW MINUTES ON BATTERY POWER, HOWEVER, A LOW BATTERY ALARM WAS TRIGGERED WHEN THE DEVICE SHUT DOWN. A "REPLACE SENSOR" ERROR MESSAGE WAS DISPLAYED AND MEASUREMENTS COULD NOT BE OBTAINED AS A RESULT OF RECESSED PINS AT THE PATIENT CABLE CONNECTOR.
OTHER, OTHER TEXT: UDI RELATED DATA QUALITY UPDATES ONLY. THIS CORRECTION UPDATES THE UDI INFORMATION, 510K NUMBER, AND MODEL NUMBER TO ENSURE ALIGNMENT WITH GUDID. THE 510K NUMBER IN GUDID WAS UPDATED TO K212161 TO CORRESPOND WITH MASIMO'S 4-DIGIT MODEL NUMBER (9799).
THE CUSTOMER REPORTED THE RAD-97 POWERED OFF BY ITSELF EVEN WHEN THE DEVICE BATTERY WAS FULLY CHARGED AND HAS AN INTERMITTENT PROBLEM WITH READING SPO2. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
THE CUSTOMER REPORTED THE RAD-97 POWERED OFF BY ITSELF EVEN WHEN THE DEVICE BATTERY WAS FULLY CHARGED AND HAS AN INTERMITTENT PROBLEM WITH READING SPO2. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
THE CUSTOMER REPORTED THE RAD-97 POWERED OFF BY ITSELF EVEN WHEN THE DEVICE BATTERY WAS FULLY CHARGED AND HAS AN INTERMITTENT PROBLEM WITH READING SPO2. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1303765 | RAD-97 PULSE CO-OXIMETER WITH NOMOLINE CAPNOGRAPHY | MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS) | MWI | MASIMO - 15750 ALTON PKWY | 9799 | 00843997012782 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |