MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-09-30 for SPIROLAB II * manufactured by Sdi Diagnostics, Inc..
[17274790]
The machine would not register when the patient blew into the turbine. Unable to get results when attempting testing on patient. Patient was transferred to sister facility where testing was completed. ======================manufacturer response for spirometer, spirolab ii (per site reporter). ======================the display, battery pack, main pcb connector, cable connector, cable cover and mouthpiece holder need to be replaced.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4187961 |
| MDR Report Key | 4187961 |
| Date Received | 2014-09-30 |
| Date of Report | 2014-09-29 |
| Report Date | 2014-09-29 |
| Date Reported to FDA | 2014-09-30 |
| Date Reported to Mfgr | 2014-10-21 |
| Date Added to Maude | 2014-10-21 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPIROLAB II |
| Generic Name | SPIROMETER |
| Product Code | BZG |
| Date Received | 2014-09-30 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | PATIENT |
| Device Availability | R |
| Device Age | 10 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SDI DIAGNOSTICS, INC. |
| Manufacturer Address | 10 HAMPDEN DR. SOUTH EASTON MA 02375 US 02375 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-09-30 |