FDA Adverse Event
Malfunction
Summary report: N
RESPIRONICS
MDR report key: 11984101
·
Received June 11, 2021
Report
- Report Number
- 2031642-2021-04046
- Event Type
- Malfunction
- Date Received
- June 11, 2021
- Date of Event
- May 17, 2021
- Manufacturer
- RESPIRONICS CALIFORNIA, LLC
- Product Code
- MNT
- UDI-DI
- 00884838020054
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
THE MANUFACTURER'S FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE SITE AND CONFIRMED THE REPORTED PROBLEM. COOLING FAN RPM NOT SHOWING. VERIFIED CONNECTIONS. THE FSE REPLACED THE CPU PCBA WITH CUSTOMER TO RESOLVE THE ISSUE. COOLING FAN RPM DISPLAYED AFTER REPAIR. NO FURTHER ERRORS WERE FOUND. ALL TESTS PASSED PER SERVICE MANUAL REQUIREMENTS.
Description of Event or Problem · 1
THE CUSTOMER CALLED INTO TECHNICAL SUPPORT (TS) REPORTING FAN ERROR AND HAS QUESTIONS ABOUT SOFTWARE INPUT. THE CUSTOMER REPORTED THERE WAS NO PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 882529 | RESPIRONICS | VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE | MNT | RESPIRONICS CALIFORNIA, LLC | V60 | 00884838020054 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |