MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2008-07-15 for MAVIG 1624520 0725050-05 manufactured by Mavig. Gmbh.
[19461982]
Hospital describes the event as follows: the dr was attempting to move the shield assembly and realized, it was stuck. He forced the arm to get it free of obstruction and the assembly broke off. Striking him as it feel to the floor.
Patient Sequence No: 1, Text Type: D, B5
[19716220]
Arm was returned to us for evaluation on june 30th. Medwatch-equipment evaluation summary: findings: upon receipt of the broken suspension arm involved in the incident at (b) (6) hospital, it is readily apparent that this arm has been severely misused by the hospital. There is a great deal of physical evidence, in the form of deep scratching in to the paint, which shows there have been numerous collisions with other equipment in the room. The edge surfaces are scratched down to the bare metal, leaving little or no paint in many sections. This paint loss and scarring indicates that this arm has been hit repeatedly, and with force, by heavy foreign objects (i. E. Suspended lamps, shields, c-arm, etc... ). Conclusion: based on the hospital's account that the doctor was "forcing the arm free from a stuck position" and given the physical condition of the arm, it is our opinion that this arm was significantly weakened by abuse which lead to its failure.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2438931-2008-00003 |
| MDR Report Key | 1080210 |
| Report Source | 99 |
| Date Received | 2008-07-15 |
| Date of Report | 2008-06-12 |
| Date of Event | 2008-05-29 |
| Date Added to Maude | 2010-04-12 |
| 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 | 0 |
| Manufacturer Street | STAHLGRUBERRING 5 |
| Manufacturer City | MUNICH 81829 |
| Manufacturer Country | GM |
| Manufacturer Postal | 81829 |
| Manufacturer Phone | 9420960 |
| Single Use | 0 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAVIG |
| Generic Name | HANEL |
| Product Code | KPY |
| Date Received | 2008-07-15 |
| Model Number | 1624520 |
| Catalog Number | 0725050-05 |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAVIG. GMBH |
| Manufacturer Address | MUNICH GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-07-15 |