MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-09-30 for THORPE TUBE * manufactured by Western Medica.
[1754982]
Inspection of air and oxygen flow meters performed (recall from chemtron) and found 1 with knurling defect which is a sign of flow meter disconnecting from the plate. This flow meter was not being used and was turned off. The flow meter did not dislodge from the plate (while in the wall) which potentially could project and hit someone and may also cause a ventilator to disconnect from the wall oxygen or air supply). Device has been taken out of service. Biomed called manufacturer- no response to date. ======================health professional's impression======================the defect "knurling" is 1st sign that the plate separates from the flowmeter which may potentially cause projection of the flowmeter or disconnection of a vent to the oxygen or air supply.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1883562 |
| MDR Report Key | 1883562 |
| Date Received | 2010-09-30 |
| Date of Report | 2010-09-30 |
| Date of Event | 2010-07-15 |
| Report Date | 2010-09-30 |
| Date Reported to FDA | 2010-09-30 |
| Date Added to Maude | 2010-10-26 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THORPE TUBE |
| Generic Name | BACK-PRESSURE COMPENSATED OXYGEN FLOWMETER |
| Product Code | CAX |
| Date Received | 2010-09-30 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Age | 15 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WESTERN MEDICA |
| Manufacturer Address | 875 BASSETT RD WESTLAKE OH 44145 US 44145 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-09-30 |