MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-13 for HUDSON-RCI VOLDYNE 2500SERIES manufactured by Teleflex Medical.
[114076081]
Caller reported that the device was used on her father to treat fluid in the lungs with crackles and possibly led to his death. Her father had anemia, possible congestive heart failure, acute kidney injury, possible pneumonia and was not on antibiotics. Pt had been treated with digoxin and aspirin prior device use. Caller is questioning if it is safe to use this device on a pt with these diagnosis and who is on oxygen. She does not want this to happen to another person.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5078409 |
| MDR Report Key | 7689356 |
| Date Received | 2018-07-13 |
| Date of Report | 2018-07-13 |
| Date of Event | 2017-08-20 |
| Date Added to Maude | 2018-07-16 |
| 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 |
| 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 | 3 |
| Brand Name | HUDSON-RCI VOLDYNE 2500SERIES |
| Generic Name | VOLUMETRIC EXERCISER (SPIROMETER THERAPEUTIC INCENTIVE) |
| Product Code | BWF |
| Date Received | 2018-07-13 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | 2917 WECK DR NC 27709 US 27709 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2018-07-13 |