MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2020-01-08 for BIPAP FOCUS NONINVASIVE VENTILATOR SYSTEM manufactured by Respironics California, Inc.
[181420176]
Date of event: (b)(6) 2019. Date of report: 01/08/2020.
Patient Sequence No: 1, Text Type: N, H10
[181420177]
It was reported that the ventilator's battery has run out and the ventilator does not switch on anymore. The system comes up with a loud beep and battery not present error. There was no patient involvement. The customer was sent a quote for service and replacement of battery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2031642-2020-00100 |
| MDR Report Key | 9565441 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2020-01-08 |
| Date of Report | 2019-12-23 |
| Date Mfgr Received | 2019-12-23 |
| Device Manufacturer Date | 2007-06-12 |
| Date Added to Maude | 2020-01-08 |
| 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 | MR. DAVID MCGRATH |
| Manufacturer Street | 3000 MINUTEMAN ROAD |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal | 01810 |
| Manufacturer Phone | 9786871501 |
| 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 | 2020-01-08 |
| 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 | 2020-01-08 |