MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-08-11 for OHMEDA FLOW TRANSDUCER 22F/22M UNK manufactured by Ohmeda Inc..
[19951765]
Flow transducer tubing found to be cracked during pre-check of anesthesia delivery system. Staff report that there have been approximately 4 to 5 other incidents of cracked tubing prior to this event. No incidents have caused any harm to pts.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1016942 |
| MDR Report Key | 235368 |
| Date Received | 1999-08-11 |
| Date of Report | 1999-08-05 |
| Date of Event | 1999-07-01 |
| Date Added to Maude | 1999-08-17 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OHMEDA FLOW TRANSDUCER |
| Generic Name | FLOW TRANSDUCER |
| Product Code | BXP |
| Date Received | 1999-08-11 |
| Model Number | 22F/22M |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | PART #: 1503-3067-000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 228098 |
| Manufacturer | OHMEDA INC. |
| Manufacturer Address | OHMEDA DR. MADISON WI 53707 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1999-08-11 |