MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-08 for TIDI PRODUCTS ZERO-GRAVITY ZGCM-HSA manufactured by Tidi Products, Llc.
[62340934]
Patient Sequence No: 1, Text Type: N, H10
[62340935]
Body shield frame tube slipped out of the clamp block due to all four clamp bolts being loosened. The hospital reports that they did not loosen the four bolts, but tidi products believes that somehow those bolts had to have been loosened not long before the incident. The original installer report indicates that the bolts were tight at installation, the history of >400 other installations seems to indicate that the bolts will not loosen randomly or due to some other influence, and the behavior of the system is sufficiently different with the bolts loose that we are confident their loose status would have been noticed by users if it had persisted for long before the incident. Our working theory is that someone associated with the hospital may have loosened the bolts so as to remove the body shield for periodic fluoroscopic radiation-shield checking (i. E. State law requirement), then failed to fully re-tighten them upon re-hanging the body shield. Note that this means of fluoroscoping the body shield is contrary to the procedure detailed in the user manual. Coincidentally, tidi products' product representative (b)(6) was on his way to the hospital that day, and learned of the issue upon arrival. So, he properly re-installed the body shield with tightened bolts. Note that there was no cable breakage or other issue that might be related to cable issues.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1825560-2016-00003 |
| MDR Report Key | 6156892 |
| Date Received | 2016-12-08 |
| Date of Report | 2016-12-02 |
| Date of Event | 2016-11-02 |
| Date Mfgr Received | 2016-11-02 |
| Device Manufacturer Date | 2015-09-28 |
| Date Added to Maude | 2016-12-08 |
| 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 |
| Reporter Occupation | SERVICE AND TESTING PERSONNEL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JOHN SCHAEFER |
| Manufacturer Street | 14241 FENTON ROAD |
| Manufacturer City | FENTON MI 48430 |
| Manufacturer Country | US |
| Manufacturer Postal | 48430 |
| Manufacturer Phone | 8107505300 |
| Manufacturer G1 | TIDI PRODUCTS, LLC |
| Manufacturer Street | 14241 FENTON ROAD |
| Manufacturer City | FENTON MI 48430 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 48430 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | TIDI PRODUCTS ZERO-GRAVITY |
| Generic Name | RADIATION SHIELD SYSTEM |
| Product Code | EAJ |
| Date Received | 2016-12-08 |
| Model Number | ZGCM-HSA |
| Catalog Number | ZGCM-HSA |
| Lot Number | 575365 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TIDI PRODUCTS, LLC |
| Manufacturer Address | 14241 FENTON ROAD FENTON MI 48430 US 48430 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-12-08 |