MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-19 for V60 VENTILATOR manufactured by Respironics California, Inc.
[186360377]
Date of event: (b)(6) 2020. Date of report: 19mar2020.
Patient Sequence No: 1, Text Type: N, H10
[186360378]
Problem identified during investigation of a returned user interface (ui). Failure investigation identified and confirmed failure of the navigation (nav) ring of the returned ui. The device did not have patient involvement at the time the issue was discovered, therefore, there was no patient or user harm reported. The user interface was changed out to resolve another failure and nav ring failure was identified during failure investigation. A user interface assembly was returned for analysis. An investigation was performed and malfunction of the nav ring is noted. Duplicated customer complaint, fault is found on testing. The electrical failure confirmed out of specification. Dye penetrant testing revealed liquid ingress path to encoder internal circuitry. Component failed due to contamination ingress into nav ring encoder.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2031642-2020-00966 |
| MDR Report Key | 9857364 |
| Report Source | USER FACILITY |
| Date Received | 2020-03-19 |
| Date of Report | 2019-11-07 |
| Date Mfgr Received | 2020-02-28 |
| Device Manufacturer Date | 2016-06-14 |
| Date Added to Maude | 2020-03-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. MELISSA ABBOTT |
| Manufacturer Street | 2271 COSMOS COURT |
| Manufacturer City | CARLSBAD CA 92011 |
| Manufacturer Country | US |
| Manufacturer Postal | 92011 |
| Manufacturer Phone | 9093746996 |
| Manufacturer G1 | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Street | 3000 MINUTEMAN ROAD |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01810 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | V60 VENTILATOR |
| Generic Name | VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE |
| Product Code | MNT |
| Date Received | 2020-03-19 |
| Model Number | V60 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RESPIRONICS CALIFORNIA, INC |
| Manufacturer Address | 2271 COSMOS COURT CARLSBAD CA 92011 US 92011 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-19 |