FDA Adverse Event
Malfunction
Summary report: N
RD SET TC-I
MDR report key: 7288078
·
Received February 21, 2018
Report
- Report Number
- 2031172-2018-00110
- Event Type
- Malfunction
- Date Received
- February 21, 2018
- Date of Event
- January 29, 2018
- Manufacturer
- MASIMO - 40 PARKER
- Product Code
- DPZ
- UDI-DI
- 00843997009904
- PMA / PMN Number
- K051212
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS BEEN RETURNED TO THE LOCAL FACILITY BUT HAS NOT YET BEEN RECEIVED AT THE MAIN OFFICE FOR EVALUATION. ONCE THE DEVICE HAS BEEN RETURNED AND INVESTIGATED, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Additional Manufacturer Narrative · 1
THE RETURNED SENSOR WAS EVALUATED. DURING EVALUATION THE SENSOR PASSED ALL VISUAL AND FUNCTIONAL TESTING. THE SENSOR WAS DETERMINED TO BE FUNCTIONING AS DESIGNED., CORRECTED DATA: D2B PROCODE: WAS CORRECTED FROM DQA TO DPZ..
Description of Event or Problem · 1
THE CUSTOMER REPORTED INACCURATE VALUES. ADDITIONALLY THE CUSTOMER REPORTED FAILED READINGS ACCOMPANIED BY AN ERROR MESSAGE. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 129836 | RD SET TC-I | OXIMETER | DPZ | MASIMO - 40 PARKER | 4053-9 | 17AKM | 00843997009904 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |