MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-02-11 for VITAL SIGNS? HEAD POSITIONER 8000HDP manufactured by Vyaire Medical.
[135870267]
At this time, vyaire has not received the suspect device/component for evaluation. Even though a root cause could not be determined, (b)(4) was initiated to investigate this issue.
Patient Sequence No: 1, Text Type: N, H10
[135870268]
It was reported to vyaire that the patient's face had blisters and skin issues associated with the head positioner. The customer confirmed that there was no serious harm associated with the reported issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030673-2019-00029 |
| MDR Report Key | 8327382 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-02-11 |
| Date of Report | 2019-01-15 |
| Date of Event | 2019-01-14 |
| Date Mfgr Received | 2019-01-15 |
| Date Added to Maude | 2019-02-11 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. STANLEY TAN |
| Manufacturer Street | 22745 SAVI RANCH PKWY |
| Manufacturer City | YORBA LINDA CA 92887 |
| Manufacturer Country | US |
| Manufacturer Postal | 92887 |
| Manufacturer Phone | 7149193324 |
| Manufacturer G1 | PRODUCTOS UR |
| Manufacturer Street | CERRADA V # 85 PARQUE INDUSTRIAL |
| Manufacturer City | MEXICALI, 21397 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 21397 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VITAL SIGNS? HEAD POSITIONER |
| Generic Name | PRONE HEAD POSITIONER WITH MIRROR |
| Product Code | HBM |
| Date Received | 2019-02-11 |
| Catalog Number | 8000HDP |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VYAIRE MEDICAL |
| Manufacturer Address | 22745 SAVI RANCH PKWY YORBA LINDA CA 92887 US 92887 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-11 |