MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2012-04-06 for TRITON SPINE THERAPY TABLE TRT600 manufactured by Djo, Llc.
[2809619]
No pts were involved, the sales rep was performing an in service at the customer's office, he pulled down the hand lever, the weld broke and the smaller chest/head section broke. Initial info provided to djo on (b)(6) 2012, was insufficient in that it did not suggest that device failed to meet specifications or malfunctioned. The initial info provided did not suggest that if the alleged malfunction or failure to meet specifications were to recur it would cause or contribute to death or serious injury. Photos of the broken weld were sent to djo. The photos revealed that the weld under the chest/head section (which supports the pt's upper body including neck and back) is broken. Although a pt was not involved, the photos reveal that a malfunction of the device occurred, and suggest that would the malfunction were to recur, it can possibly cause or contribute to a death or serious injury. Given the new info djo has classified the product problem as a reportable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616086-2012-00021 |
| MDR Report Key | 2545968 |
| Report Source | 08 |
| Date Received | 2012-04-06 |
| Date of Report | 2012-04-05 |
| Date Mfgr Received | 2012-03-07 |
| Date Added to Maude | 2012-09-10 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 1430 DECISION ST |
| Manufacturer City | VISTA CA 92081 |
| Manufacturer Country | US |
| Manufacturer Postal | 92081 |
| Manufacturer Phone | 7607271280 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRITON SPINE THERAPY TABLE |
| Generic Name | TRACTION POWERED -TABLES AND TRACTION |
| Product Code | IRS |
| Date Received | 2012-04-06 |
| Model Number | TRT600 |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DJO, LLC |
| Manufacturer Address | VISTA CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-04-06 |