MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-09 for EASYPULSES manufactured by Precision Medical.
[91756488]
I'm on support oxygen due to copd. O2 is supplied from an o2 bottle thru a valve made by precision medical. The valve in question is easypulses. This valve is not working correctly. In the middle of the night and i almost did not recover from lack of correct supply. Valve no longer pulses oxygen and gave me too much. I called company and they were rude and uncaring. I believe the company has upgraded their valve but never let the supplier or consumer know that it has a defect.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5073190 |
| MDR Report Key | 7013451 |
| Date Received | 2017-11-09 |
| Date of Report | 2017-11-07 |
| Date of Event | 2017-11-07 |
| Date Added to Maude | 2017-11-09 |
| 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 | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | EASYPULSES |
| Generic Name | EASYPULSES |
| Product Code | NFB |
| Date Received | 2017-11-09 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PRECISION MEDICAL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2017-11-09 |