FDA Adverse Event
Malfunction
Summary report: N
RESPIRONICS
MDR report key: 13193064
·
Received January 7, 2022
Report
- Report Number
- 2031642-2022-00087
- Event Type
- Malfunction
- Date Received
- January 7, 2022
- Date of Event
- December 28, 2021
- Manufacturer
- RESPIRONICS CALIFORNIA, LLC
- Product Code
- MNT
- PMA / PMN Number
- K102985
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
(B)(6).
Additional Manufacturer Narrative · 0
UPON FURTHER INVESTIGATION, THERE IS NO COMPLAINT OR ALLEGATION OF MALFUNCTION. THEREFORE THIS COMPLAINT NO LONGER MEETS REPORTABILITY REQUIREMENTS.
Description of Event or Problem · 0
THE CUSTOMER ORDERED FOR A V60 WHITE TOP COVER, WITH PART NUMBER 1111270 AND ITEM NUMBER 453561531971. IT IS UNKNOWN HOW THE DEVICE WAS BEING USED AT THE TIME THIS INCIDENT OCCURRED, HOWEVER, THERE WAS NO REPORT OF PATIENT OR USER HARM. FURTHER INFORMATION REGARDING THIS EVENT HAVE BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2498830 | RESPIRONICS | VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE | MNT | RESPIRONICS CALIFORNIA, LLC | V60 PLUS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |