MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-02-21 for BIPAP FOCUS NONINVASIVE VENTILATOR SYSTEM manufactured by Respironics California, Inc.
[183930848]
Date of event: (b)(6 2020. Date of report: 21feb2020.
Patient Sequence No: 1, Text Type: N, H10
[183930849]
The customer reported that the device had experienced an over pressure condition. The device was not sent to bench repair due to the device no longer being serviced. The device was not in clinical use at the time the issue was discovered. There was no patient or user harm reported. The device was no longer being supported so the customer decided to retire the device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2031642-2020-00579 |
| MDR Report Key | 9742370 |
| Report Source | USER FACILITY |
| Date Received | 2020-02-21 |
| Date of Report | 2020-01-29 |
| Date Mfgr Received | 2020-01-29 |
| Device Manufacturer Date | 2010-08-19 |
| Date Added to Maude | 2020-02-21 |
| 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 | BIPAP FOCUS NONINVASIVE VENTILATOR SYSTEM |
| Generic Name | VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING |
| Product Code | MNS |
| Date Received | 2020-02-21 |
| Model Number | NA |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| 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 | 2020-02-21 |