MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-03-20 for AUTO SPIRO SPIROMETER manufactured by Gemtech Corp..
[17409]
The spirometer used in the office gives much different readings than the spirometer hospitals use. This even though the pt is seen only minutes later at the hospital. Also, the mfr refuses to send neccesary parts, replacement parts, which would make the spirometer work better.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4001127 |
| MDR Report Key | 31403 |
| Date Received | 1996-03-20 |
| Date of Report | 1995-10-02 |
| Date Added to Maude | 1996-03-27 |
| 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 | PATIENT |
| 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 | AUTO SPIRO SPIROMETER |
| Generic Name | SPIROMETER |
| Product Code | BZG |
| Date Received | 1996-03-20 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 32522 |
| Manufacturer | GEMTECH CORP. |
| Manufacturer Address | 1683 E KENT AVE CHANDLER AZ 85255 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-03-20 |