MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-20 for V60 VENTILATOR 1053617 manufactured by Respironics California, Inc.
[186606976]
Date of event: (b)(6) 2020. Date of report: 20mar2020.
Patient Sequence No: 1, Text Type: N, H10
[186606977]
The customer reported the ventilator shut down while on a patient. They also found the "pressure regulation high" diagnostic code in the error log. The device was being used for treatment when the reported event occurred; however, there was no patient harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2031642-2020-00983 |
| MDR Report Key | 9862329 |
| Report Source | USER FACILITY |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-03 |
| Date Mfgr Received | 2020-03-03 |
| Device Manufacturer Date | 2018-01-18 |
| Date Added to Maude | 2020-03-20 |
| 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 | 2020-03-20 |
| Model Number | V60 |
| Catalog Number | 1053617 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-03-20 |