MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-11-15 for DORNIER LITHOTRIPTER SII DOLI SII manufactured by Dornier Medtech Systems, Gmbh.
[15102891]
After treatment, the pt attempted to step off of the stretcher, the foot section loosened and the pt fell on his head, receiving a laceration. Event took place in (b)(6).
Patient Sequence No: 1, Text Type: D, B5
[15464675]
The customer has a service contract with dmts and at the last servicing in (b)(4) 2013, the foot section was functioning properly. We conclude that the issue was not caused by a design flaw, but was a result of the foot section falling to the floor sometime before this incident and suffering a bend that was overlooked by the customer. The pt required sutures to the head laceration and is recovering. Dmts field service engineer instructed customer to exchange the bent lever before next treatment. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1037955-2013-00022 |
| MDR Report Key | 3522516 |
| Report Source | 07 |
| Date Received | 2013-11-15 |
| Date of Report | 2013-11-12 |
| Date of Event | 2013-10-22 |
| Date Facility Aware | 2013-11-12 |
| Report Date | 2013-11-15 |
| Date Reported to FDA | 2013-11-15 |
| Date Reported to Mfgr | 2013-11-15 |
| Date Mfgr Received | 2013-11-12 |
| Device Manufacturer Date | 2004-09-01 |
| Date Added to Maude | 2013-12-18 |
| 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 |
| Manufacturer Contact | LIZBETH AULT |
| Manufacturer Street | 1155 ROBERTS BLVD. |
| Manufacturer City | KENNESAW GA 30144 |
| Manufacturer Country | US |
| Manufacturer Postal | 30144 |
| Manufacturer Phone | 7705146188 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DORNIER LITHOTRIPTER SII |
| Generic Name | DOLI SII |
| Product Code | KQS |
| Date Received | 2013-11-15 |
| Model Number | DOLI SII |
| Catalog Number | DOLI SII |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 9 YR |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DORNIER MEDTECH SYSTEMS, GMBH |
| Manufacturer Address | WESSLING, BAVARIA GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-11-15 |