MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-16 for EMERSON CA-3200 COUGH ASSIST MACHINE PORTABLE PATIENT RESPIRATORY AIR OXYGEN manufactured by Respironics.
[75529843]
I ordered a cough assist, ca-3200 respiratory machine from an authorized dealer from the (b)(6). I bought it off (b)(6) and they stated that the machine was completely refurbished and in excellent working condition. Total cost for machine, hoses and mask, and step up transformer, about (b)(6) dollars. The machine is faulty, does not work at all, won't even turn on. My father has muscular dystrophy and is 100 percent disabled and has breathing problems that this machine could help with.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5069832 |
| MDR Report Key | 6575506 |
| Date Received | 2017-05-16 |
| Date of Report | 2017-05-16 |
| Date of Event | 2017-04-04 |
| Date Added to Maude | 2017-05-18 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | EMERSON CA-3200 COUGH ASSIST MACHINE PORTABLE PATIENT RESPIRATORY AIR OXYGEN |
| Generic Name | POSITIVE PRESSURE BREATHING |
| Product Code | NHJ |
| Date Received | 2017-05-16 |
| Model Number | CA-3200 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RESPIRONICS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-05-16 |