MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-03-28 for ONE AND TWO STAGE REGULATOR manufactured by Chemetron Medical Div. Allied Healthcare Products, Inc..
[10372]
Liter flow gauge needle would stop at 4 l and not return to zero and go past 15 and not return to zero. There is also leaking oxygen at shaft connection and co was recalling regulators for a spring not able to withstand pressure. Event dates: 7/21/93, 7/24/93 and 7/27/93. (*)
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1001241 |
| MDR Report Key | 12316 |
| Date Received | 1994-03-28 |
| Date of Event | 1993-07-21 |
| Date Added to Maude | 1994-03-29 |
| 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 |
| 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 | ONE AND TWO STAGE REGULATOR |
| Generic Name | OXYGEN THERAPY REGULATORS |
| Product Code | CCN |
| Date Received | 1994-03-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 12316 |
| Manufacturer | CHEMETRON MEDICAL DIV. ALLIED HEALTHCARE PRODUCTS, INC. |
| Manufacturer Address | ST. LOUIS MO 63110 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1994-03-28 |