FDA Adverse Event
Malfunction
Summary report: N
V60 VENTILATOR
MDR report key: 8921170
·
Received August 22, 2019
Report
- Report Number
- 2031642-2019-06898
- Event Type
- Malfunction
- Date Received
- August 22, 2019
- Report Date
- August 6, 2019
- Manufacturer
- RESPIRONICS CALIFORNIA, INC
- Product Code
- MNT
- PMA / PMN Number
- K082660
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
DATE REC'D FROM MFR: 20NOV2019. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS DEVICE'S EVALUATION AND REPAIR. THE CUSTOMER DID NOT RESPOND TO THESE ATTEMPTS. THIS COMPLAINT WILL BE CLOSED. SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, DISTRIBUTOR, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.
Additional Manufacturer Narrative · 1
DATE OF EVENT: (B)(6). DATE OF REPORT: 22AUG2019.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT TIDAL VOLUMES ARE READING HIGH. THERE WAS NO PATIENT OR USER HARM REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 713503 | V60 VENTILATOR | VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE | MNT | RESPIRONICS CALIFORNIA, INC | V60 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |