MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05,06 report with the FDA on 2008-02-04 for DISPOSA-HOOD * 0305W manufactured by Utah Medical Products, Inc..
[7946664]
A failure analysis by outside firm has been initiated by the hospital. A laboratory test conducted by utmd under simulated conditions indicated that the hood itself would not combust. It would deform and possibly collapse. Utmd has contacted the fire department to assist in it's investigation. Utmd will assist outside firm, as needed. The hood has been in use for 25 years (over 2 million uses) without a similar reported event. Utmd will provide add'l info as it becomes available.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1718873-2008-00002 |
| MDR Report Key | 990606 |
| Report Source | 00,05,06 |
| Date Received | 2008-02-04 |
| Date Mfgr Received | 2008-01-30 |
| Date Added to Maude | 2008-02-05 |
| 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 | 0 |
| Manufacturer Contact | BEN SHIRLEY, VP |
| Manufacturer Street | 7043 SOUTH 300 WEST |
| Manufacturer City | MIDVALE UT 84047 |
| Manufacturer Country | US |
| Manufacturer Postal | 84047 |
| Manufacturer Phone | 8015661200 |
| Manufacturer G1 | UTAH MEDICAL PRODUCT, INC |
| Manufacturer Street | 7043 SOUTH 300 WEST |
| Manufacturer City | MIDVALE UT 84047 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 84047 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DISPOSA-HOOD |
| Generic Name | DISPOSABLE OXYGEN HOOD |
| Product Code | FOG |
| Date Received | 2008-02-04 |
| Model Number | * |
| Catalog Number | 0305W |
| Lot Number | UNK |
| ID Number | * |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 959201 |
| Manufacturer | UTAH MEDICAL PRODUCTS, INC. |
| Manufacturer Address | 7043 SOUTH 300 WEST MIDVALE UT 840471048 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-02-04 |