MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-07 for MICRO manufactured by Vyaire Medical, Inc..
[76848780]
Patient Sequence No: 1, Text Type: N, H10
[76848781]
A total of (b)(4) units over the last approximately 2 years that did not work when they arrived or were returned by the patients so we needed to swap them out. The devices either will not charge, hold a charge or power on after a full charge. This appears to be a quality control issue or product durability issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6618131 |
| MDR Report Key | 6618131 |
| Date Received | 2017-06-07 |
| Date of Report | 2017-05-22 |
| Date of Event | 2017-05-22 |
| Report Date | 2017-05-22 |
| Date Reported to FDA | 2017-05-22 |
| Date Reported to Mfgr | 2017-05-22 |
| Date Added to Maude | 2017-06-07 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| 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 | MICRO |
| Generic Name | SPIROMETER, DIAGNOSTIC |
| Product Code | BZG |
| Date Received | 2017-06-07 |
| Model Number | MICRO |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VYAIRE MEDICAL, INC. |
| Manufacturer Address | 22745 SAVI RANCH PKWY. YORBA LINDA CA 92887 US 92887 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-07 |