MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 1999-08-04 for OHIO PRESSURE COMPENSATED FLOWMETER 6715-1292-921 manufactured by Ohmeda Medical.
[159889]
It was reported that on 6/30/99 a nurse placed the subject device into a wall outlet and heard a hissing noise. She placed it in a second outlet and heard the hissing noise again. She then placed it in a third outlet and the outer shroud "flew into the air" and shattered into 4 pieces onto the floor. There was no injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1121732-1999-00006 |
| MDR Report Key | 234495 |
| Report Source | 01,05,07 |
| Date Received | 1999-08-04 |
| Date of Event | 1999-06-30 |
| Date Mfgr Received | 1999-07-08 |
| Date Added to Maude | 1999-08-06 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Manufacturer Phone | ** |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OHIO PRESSURE COMPENSATED FLOWMETER |
| Generic Name | PRESSURE COMPENSATED FLOWMETER |
| Product Code | CCN |
| Date Received | 1999-08-04 |
| Model Number | NA |
| Catalog Number | 6715-1292-921 |
| Lot Number | NA |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 227274 |
| Manufacturer | OHMEDA MEDICAL |
| Manufacturer Address | 9065 GUILFORD RD. COLUMBIA MD 21046 US |
| Baseline Brand Name | OHMEDA PRESSURE COMPENSATED OXYGEN FLOWMASTER |
| Baseline Generic Name | PRESSURE COMPENSATED FLOWMASTER |
| Baseline Model No | NA |
| Baseline Catalog No | 6715-1292-921 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1999-08-04 |