MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-28 for NV UMFFM SYS MED STD-EUR1 60645 manufactured by Resmed Ltd.
[37058871]
An investigation carried out by the (b)(4) hospital determined that there was no malfunction with the mask. It was reported that the physician accepted most likely cause of death was from a leak from the patient's circuit. The mask was not returned to resmed for investigation. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[37058872]
It was reported to resmed (b)(4) that a hospital patient passed away due to a circuit disconnection while using a resmed ultra mirage nv full face mask with a carefusion ventilator.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004604967-2016-00065 |
| MDR Report Key | 5397488 |
| Date Received | 2016-01-28 |
| Date of Report | 2016-01-28 |
| Date of Event | 2015-12-31 |
| Date Facility Aware | 2015-12-31 |
| Date Mfgr Received | 2015-12-31 |
| Date Added to Maude | 2016-01-28 |
| 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 | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. DAVID DULEY |
| Manufacturer Street | 9001 SPECTRUM CENTER BLVD |
| Manufacturer City | SAN DIEGO CA 92123 |
| Manufacturer Country | US |
| Manufacturer Postal | 92123 |
| Manufacturer Phone | 8588365985 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | NV UMFFM SYS MED STD-EUR1 |
| Generic Name | MASK, OXYGEN |
| Product Code | KGB |
| Date Received | 2016-01-28 |
| Model Number | 60645 |
| Catalog Number | 60645 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RESMED LTD |
| Manufacturer Address | 1 ELIZABETH MACARTHUR DRIVE BELLA VISTA, NSW 2153 AS 2153 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2016-01-28 |