MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-03-30 for VOLDYNE VOLUMETRIC EXERCISER 884-719009 manufactured by Sherwood Medical Co..
[9716]
Product is designed to measure inhaled volume. When using device with optimum inspiratory flow, the device does not read any volume. This results in a very false low reading and may result in pts getting add'l therapy they didn't really need. Event occurred week of 3/14-18.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1001335 |
| MDR Report Key | 12413 |
| Date Received | 1994-03-30 |
| Date of Report | 1994-03-18 |
| Date Added to Maude | 1994-03-31 |
| 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 |
| Reporter Occupation | RESPIRATORY THERAPIST |
| 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 | VOLDYNE VOLUMETRIC EXERCISER |
| Product Code | BZG |
| Date Received | 1994-03-30 |
| Catalog Number | 884-719009 |
| Lot Number | 300241, 300244, 300051 |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 12413 |
| Manufacturer | SHERWOOD MEDICAL CO. |
| Manufacturer Address | ST LOUIS MO 63103 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1994-03-30 |