MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-11-06 for DORNIER RELAX + TABLE K1018869 manufactured by Dornier Medtech Systems Gmbh.
[18277553]
Six of the eight caps screw that mount the k axis to the pt stretcher were missing and not located within the frame. The k axis drive separated from the linear bearing guide allowing the table top to angle downward when the pt made a sudden and drastic movement. There was no injury reported.
Patient Sequence No: 1, Text Type: D, B5
[18322131]
The field service engineer spoke with tech about the table dramatically dropping by the foot end during treatment and decided that an inspection was necessary. With covers on, there was no apparent damage to unit until pressure was placed on the foot action and the table gave little resistance. Upon removing covers, discovered that the slide rail interconnect bracket was cocked to one side, hardware was missing and two connecting battens were severely bent. In addition, the k axis drive shaft was bent and the gas springs were cracked at the ball joint. Each rear slide rail is supposed to have 4 bolts holding it to the interconnect bracket. On one side, there were 2 bolts remaining. One of those bolts was bent and stripped while the other was completely backed out and only held up by the micro switch plate. On the other side, only one bolt was left but was only held up by the micro switch plate. No additional hardware was discovered in the bottom of the unit, in the struck or by the drivers. The table was installed on 9/17/2010. This table was recently painted by the customer. After consulting with tech support, it is unlikely that these screws were left out during manufacturing. The table was manufactured on 7/7/2010, all manufacturing records were reviewed and indicate that the product met all final product release criteria and was manufactured and tested in accordance with all applicable procedures. It is likely that the screws were removed or misplaced by the customer during painting or during transportation. (b)(4) (the importer) is submitting the report on behalf of dornier medtech systems (b)(4) (the manufacturer) per (b)(4)...
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1037955-2012-00024 |
| MDR Report Key | 2852933 |
| Report Source | 06 |
| Date Received | 2012-11-06 |
| Date of Report | 2012-11-06 |
| Date Facility Aware | 2012-10-08 |
| Report Date | 2012-11-06 |
| Date Mfgr Received | 2012-10-08 |
| Device Manufacturer Date | 2010-07-01 |
| Date Added to Maude | 2012-12-03 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | JAMIE BRADSHAW |
| Manufacturer Street | 1155 ROBERTS BLVD. |
| Manufacturer City | KENNESAW GA 30144 |
| Manufacturer Country | US |
| Manufacturer Postal | 30144 |
| Manufacturer Phone | 7705146141 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DORNIER RELAX + TABLE |
| Generic Name | TABLE |
| Product Code | KQS |
| Date Received | 2012-11-06 |
| Model Number | K1018869 |
| Lot Number | 540 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 12 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 | 2012-11-06 |