MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-01-14 for ONDAL ACROBAT 2000 manufactured by Ondal Industrietechnik Gmbh.
[21410307]
Report from (b)(6) of metal fatigue failures of a weld seam on spring arms mfg by ondal industrietechnik (b)(4) and sold under the trade name of "acrobat 2000. " specific info about the actual failures is unk. On (b)(6) 2009, it was learned that ondal performed testing of its spring arm through (b)(4). It was reported that when sample acrobat 2000 spring arms fully extended with a weight of 20. 3 kg placed 700 mm from the weld joint, could fail on average after 8. 72 years of use. The ondal acrobat 2000 spring arms are evidently the subject of regulatory activity in (b)(6). There are no reported or known failures of the acrobat 2000 in the united states. Usage of the acrobat 2000 in america -surgical lighting- has involved a shorter lever arm -500 mm- and lower loading -9. 1 kg-.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5019060 |
| MDR Report Key | 1969294 |
| Date Received | 2011-01-14 |
| Date of Report | 2011-01-14 |
| Date of Event | 2011-01-01 |
| Date Added to Maude | 2011-02-02 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ONDAL ACROBAT 2000 |
| Generic Name | SPRING ARM |
| Product Code | LDE |
| Date Received | 2011-01-14 |
| Model Number | ACROBAT 2000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ONDAL INDUSTRIETECHNIK GMBH |
| Manufacturer Address | WELLASTRASSE 6 HUNFELD 36088 GM 36088 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-01-14 |