MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-23 for V60 VENTILATOR manufactured by Respironics California, Inc.
[187683026]
Date of event: (b)(6) 2020. Date of report: 03/23/2020.
Patient Sequence No: 1, Text Type: N, H10
[187683027]
It was reported that while in use, the ventilator shut down and restarted. The patient was removed from the ventilator and placed on an alternate ventilator. The patient was not harmed or injured as a result of the reported event. The service engineer (se) inspected the device. The se could not duplicate the reported issue, but did find in the ventilator diagnostic logs an error code indicating a ventilator restart had occurred on (b)(6) 2020 11:51 am. Review of the ventilator diagnostic codes found an error code indicating low inspiratory pressure, proximal pressure line disconnect, oxygen not available, low tidal volume, patient disconnect. The se replaced the central processing unit (cpu) board to address the reported issue. The unit was checked overall, run in tested, cleaned, functionally tested and no abnormality was confirmed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2031642-2020-00999 |
| MDR Report Key | 9868323 |
| Report Source | USER FACILITY |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-11 |
| Date of Event | 2020-03-05 |
| Date Mfgr Received | 2020-03-11 |
| Device Manufacturer Date | 2011-11-21 |
| Date Added to Maude | 2020-03-23 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| 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 | 2020-03-23 |
| 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 | 2020-03-23 |