MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-02 for BIPAP FOCUS NONINVASIVE VENTILATOR SYSTEM manufactured by Respironics California, Inc.
[188969949]
Date of event: (b)(6) 2020. Date of report: 03/02/2020.
Patient Sequence No: 1, Text Type: N, H10
[188969950]
It was reported that the unit declared an over pressure condition. The device was in use at the time of the event; however, there was no patient harm. The manufacturer's remote service technician performed troubleshooting with the customer. The customer ran the unit but was unable to duplicate the error. The technician recommended that the customer perform a complete check of the unit with passing results before placing the unit back in service.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2031642-2020-00695 |
| MDR Report Key | 9777487 |
| Report Source | USER FACILITY |
| Date Received | 2020-03-02 |
| Date of Report | 2020-02-06 |
| Date Mfgr Received | 2020-02-06 |
| Device Manufacturer Date | 2008-10-13 |
| Date Added to Maude | 2020-03-02 |
| 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 | 2020-03-02 |
| Model Number | NA |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2020-03-02 |