MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-05-02 for TIMETER FLOW METER 15002-03 manufactured by Allied Healthcare Products, Inc..
[1973816]
It was reported that while using oxygen in a patient room the oxygen flow meter came apart at the splines and came off the wall connector. The flow meter fell to the ground/floor. The nurse was in the patient room at the time and was able to change the flow meter immediately. There was no harm to the patient.
Patient Sequence No: 1, Text Type: D, B5
[8987036]
Flow meter involved has not yet been returned for evaluation. Age of the flow meter has not been determined. All flow meters have a date code on them when they leave allied. This type of failure could be caused by rough handling over years of use.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1924066-2011-00002 |
| MDR Report Key | 2114412 |
| Report Source | 05 |
| Date Received | 2011-05-02 |
| Date of Report | 2011-05-02 |
| Date of Event | 2011-04-13 |
| Date Mfgr Received | 2011-04-19 |
| Date Added to Maude | 2011-10-19 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 1720 SUBLETTE AVE. |
| Manufacturer City | ST. LOUIS MO 63110 |
| Manufacturer Country | US |
| Manufacturer Postal | 63110 |
| Manufacturer Phone | 3142681661 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TIMETER FLOW METER |
| Generic Name | FLOW METER |
| Product Code | CAX |
| Date Received | 2011-05-02 |
| Model Number | 15002-03 |
| Catalog Number | 15002-03 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALLIED HEALTHCARE PRODUCTS, INC. |
| Manufacturer Address | 1720 SUBLETTE AVE. ST. LOUIS MO 63110 US 63110 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-05-02 |