MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-12 for DOVAC ELITE V2.0 manufactured by It Synergistics, Llc.
[24148667]
Refer to attached report for investigation and corrective action.
Patient Sequence No: 1, Text Type: N, H10
[24148768]
The dovac elite v2. 0 system allowed the technician review process to be completed for a full length donor history questionnaire (dhq) without obtaining a response for a single question. Refer to the attached report beginning on page 4 for a complete investigation and corrective action completed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2435501-2015-00001 |
| MDR Report Key | 5004152 |
| Date Received | 2015-08-12 |
| Date of Report | 2015-08-07 |
| Date of Event | 2015-07-15 |
| Date Mfgr Received | 2015-07-15 |
| Device Manufacturer Date | 2014-04-09 |
| Date Added to Maude | 2015-08-14 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KALMAN GROF-TISZA |
| Manufacturer Street | 115 TREE ST |
| Manufacturer City | FLOWOOD MS 39232 |
| Manufacturer Country | US |
| Manufacturer Postal | 39232 |
| Manufacturer Phone | 8558667648 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DOVAC ELITE V2.0 |
| Generic Name | DOVAC ELITE V2.0 |
| Product Code | MMH |
| Date Received | 2015-08-12 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | 5 |
| Device Availability | * |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IT SYNERGISTICS, LLC |
| Manufacturer Address | FLOWOOD MS US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-08-12 |