MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,08 report with the FDA on 2014-09-17 for MIDMARK/PROGENY MC-150 R40-M-P manufactured by Quantum Medical Imaging, Llc..
[4963189]
On saturday (b)(6) at approximately 3:00 pm cst we had a situation with th ex-ray room we had purchased form quantum i have attached pictures for your review. It appears that when using the bolts supplied with the collimator there is not enough treads in the tube port mounting plate to hold the collimator in place. In this case the bolts let go and the collimator in place in this case the bolts let go and the collimator fell off. Fortunately there was not a patient under the collimator so no one was hut. The same field engineers installed this room that have done over 40 rooms in the last 4 to 5 years and we have never experienced this before. I have many more pictures as well as the serial numbers of the tube and collimator. The issue is that the bolts are 1/4 to 1/2 inch short in length. Since the operator had not control for the tubestand is also mounted with these bolts there is a constant pressure applied to these bolts every time the tubestand is moved.
Patient Sequence No: 1, Text Type: D, B5
[12474145]
After discussion with firm contracted with system installation, it was concluded that the reported incident was a result of oversight by the system installation staff int he proper selection and use of collimator mounting hardware during system set-up. Refer to attached investigation report dated (b)(4) 2014.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2438474-2014-00002 |
| MDR Report Key | 4202964 |
| Report Source | 06,08 |
| Date Received | 2014-09-17 |
| Date of Report | 2014-09-11 |
| Date of Event | 2014-09-06 |
| Date Mfgr Received | 2014-09-07 |
| Date Added to Maude | 2014-10-29 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 2002-B ORVILLE DRIVE NORTH |
| Manufacturer City | RONKONKOMA NY 117797661 |
| Manufacturer Country | US |
| Manufacturer Postal | 117797661 |
| Manufacturer Phone | 6315675800 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MIDMARK/PROGENY |
| Generic Name | DIAGNOSTIC X-RAY BEAM-LIMITING DEVICE |
| Product Code | IZW |
| Date Received | 2014-09-17 |
| Model Number | MC-150 |
| Catalog Number | R40-M-P |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | QUANTUM MEDICAL IMAGING, LLC. |
| Manufacturer Address | RONKONKOMA NY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-09-17 |