RESPIRONICS
Report
- Report Number
- 2031642-2021-05659
- Event Type
- Injury
- Date Received
- December 1, 2021
- Date of Event
- November 23, 2021
- Manufacturer
- RESPIRONICS CALIFORNIA, LLC
- Product Code
- MNT
- PMA / PMN Number
- K102985
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
(B)(6).
BASED ON THE INFORMATION RECEIVED, IT HAS BEEN IDENTIFIED THAT MFR REPORT#: 2031642-2021-05045 IS THE CORRECT REPORT AND IS THE PRIMARY COMPLAINT. MFR REPORT#: 2031642-2031642-2021-05659 HAS BEEN IDENTIFIED TO BE A DUPLICATE AND SHOULD BE NULLED.
THE CUSTOMER REPORTED THAT A VENTILATOR WAS PROVIDING INSUFFICIENT FLOW DELIVERY WITH NO NOTED VISUAL OR AUDIBLE ALARM CONDITIONS. THE V60 VENTILATOR WAS IN CLINICAL AND THERAPEUTIC USE AT THE TIME OF THE EVENT. IT WAS NOTED THAT WHILE RECEIVING HIGH FLOW THERAPY VIA THE V60 VENTILATOR, THE PATIENT EXPERIENCED A DESATURATION OF PERIPHERAL OXYGENATION (SPO2) TO AN UNSPECIFIED EXTENT AND NOTED DYSPNEA. AS PER GUIDANCE PROVIDED BY A PHILIPS REMOTE SERVICE ENGINEER, THE DEVICE WAS CHECKED FOR UNINTENTIONAL CIRCUIT LEAKS WHICH MAY WITH NONE FOUND. THE PATIENT WAS REMOVED FROM THE ALLEGED MALFUNCTIONING DEVICE AND TRANSITIONED TO A BACKUP VENTILATOR (MAKE AND MODEL UNSPECIFIED). VENTILATOR THERAPEUTIC SETTINGS, CIRCUIT CONFIGURATION, AND INTERFACES HAVE NOT BEEN REPORTED AND ARE PENDING FURTHER INQUIRY FROM THE REPORTER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1806339 | RESPIRONICS | VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE | MNT | RESPIRONICS CALIFORNIA, LLC | V60 PLUS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |