MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other report with the FDA on 2018-04-12 for PANORAMIC X-RAY MODEL PC 1000 800724-3 manufactured by Young Innovations.
[105691053]
The panoramic certified technician from tlm was doing a pm and found the proper set screws for the tube head to be missing and incorrect set screws were in the tube head. The tube head did not fall again between service calls. The correct set screws were ordered and the technician went back to the office to install them and align the tube head. Pm done. Tube head is correctly secured and realigned. No leaks found in the tube head. Resolved. Closed ad. Quality determination: the fall of the tube head could have potentially caused or contributed serious injury. Therefore, the incident has been deemed an mdr reportable event to fda.
Patient Sequence No: 1, Text Type: N, H10
[105691054]
Dr. (b)(6) told panoramic that they were re-aligning the tube head between pan and ceph and the tube head fell off the arm. It did not hit or injure any staff/patient members. The office technician mounted the tube head back onto the machine and now appear to have alignment issues.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1832462-2018-00002 |
| MDR Report Key | 7426087 |
| Report Source | HEALTH PROFESSIONAL,OTHER |
| Date Received | 2018-04-12 |
| Date of Report | 2018-04-12 |
| Date of Event | 2018-03-26 |
| Date Mfgr Received | 2018-03-26 |
| Device Manufacturer Date | 2003-03-20 |
| Date Added to Maude | 2018-04-12 |
| 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 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ADRIENNE DEMLAND |
| Manufacturer Street | 4321 GOSHEN RD. |
| Manufacturer City | FORT WAYNE IN 46818 |
| Manufacturer Country | US |
| Manufacturer Postal | 46818 |
| Manufacturer Phone | 8006542027 |
| Manufacturer G1 | YOUNG INNOVATIONS |
| Manufacturer Street | 4321 GOSHEN RD. |
| Manufacturer City | FORT WAYNE IN 46818 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46818 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PANORAMIC X-RAY MODEL PC 1000 |
| Generic Name | PC 1000 |
| Product Code | EHD |
| Date Received | 2018-04-12 |
| Model Number | 800724-3 |
| Operator | DENTIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | YOUNG INNOVATIONS |
| Manufacturer Address | 4321 GOSHEN RD. FORT WAYNE IN 46818 US 46818 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-04-12 |