MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-13 for DORNIER DELTA III K1039062 manufactured by Dornier Medtech Systems Gmbh.
[183323714]
A service report was submitted by dmta field service engineer following the evaluation of the device identified by this complaint. This technical system safety check was conducted 6 march 2020 and the findings concluded that the device was in compliance with dornier specifications. Patient hematoma is listed as a potential adverse effect and complication in the dornier delta iii operating manual. Details concerning the patient outside of the confirmation of hematoma were not provided to dmta for review. The result of this investigation revealed no defects or inconsistencies with the identified device. The review of the device conducted for this investigation concluded the identified unit (b)(4) was manufactured and functioning within dornier specifications.
Patient Sequence No: 1, Text Type: N, H10
[183323715]
Patient hematoma reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1037955-2020-00007 |
| MDR Report Key | 9829638 |
| Date Received | 2020-03-13 |
| Date of Report | 2020-03-05 |
| Date Facility Aware | 2020-03-05 |
| Report Date | 2020-03-09 |
| Date Reported to Mfgr | 2020-03-09 |
| Date Added to Maude | 2020-03-13 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DORNIER DELTA III |
| Generic Name | LITHOTRIPTER |
| Product Code | LNS |
| Date Received | 2020-03-13 |
| Model Number | DORNIER DELTA III |
| Catalog Number | K1039062 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 13 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DORNIER MEDTECH SYSTEMS GMBH |
| Manufacturer Address | ARGELSRIEDER FELD 7 WESSLING, D-82234 GM D-82234 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-13 |