FDA Adverse Event
Malfunction
Summary report: N
RESPIRONICS
MDR report key: 11520690
·
Received March 18, 2021
Report
- Report Number
- 2031642-2021-03031
- Event Type
- Malfunction
- Date Received
- March 18, 2021
- Date of Event
- February 16, 2021
- Product Code
- MNT
- UDI-DI
- 00884838020054
- PMA / PMN Number
- K102985
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
G4:(B)(6) 2021. B4: (B)(6) 2021. G5: 510K: K102985. UPON A FOLLOW-UP WITH TECHNICAL SUPPORT, THE CUSTOMER REPORTED THAT A TOUCHSCREEN WAS RECEIVED, AND IT RESOLVED THE ISSUE. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN INFORMATION ON THE DEVICE'S REPAIR/OPERATIONAL STATUS HAVE BEEN UNSUCCESSFUL.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE VENTILATOR'S TOUCHSCREEN WOULD NOT PASS CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT. THE CUSTOMER WAS ADVISED BY TECHNICAL SUPPORT TO REPLACE THE TOUCHSCREEN AND WAS PROVIDED WITH THE PART NUMBER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 415914 | RESPIRONICS | VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE | MNT | V60 | 00884838020054 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |