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 2020-03-18 for V60 VENTILATOR manufactured by Respironics California, Inc.
[186610395]
Date of event: (b)(6) 2020. Date of report: 18mar2020.
Patient Sequence No: 1, Text Type: N, H10
[186610396]
It was reported that the unit had a touchscreen failure resulting in the touch response inaccuracy. The device was being placed into use on a patient whose condition had deteriorated. The unit was started, pressure adjusted and was connected to the patient when the touchscreen stopped functioning. There was no additional patient harm reported as a result of this; as the patient was transferred to another unit. However, the patient was said to previously be in poor condition and there was a delay in therapy. The manufacturer's field service engineer (fse) performed troubleshooting and confirmed the reported issue. The fse replaced the touchscreen and user interface (ui) to power management (pm) printed circuit board assembly (pcba) cable and the issue was resolved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2031642-2020-00955 |
| MDR Report Key | 9848553 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2020-03-18 |
| Date of Report | 2020-03-10 |
| Date Mfgr Received | 2020-03-10 |
| Device Manufacturer Date | 2012-05-03 |
| Date Added to Maude | 2020-03-18 |
| 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 | 2020-03-18 |
| 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 | 2020-03-18 |