MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-04-12 for 770 INTRAORAL X-RAY SYSTEM * A0771AT manufactured by Gendex Imaging.
[19490375]
A service tech was changing the tube head and forgot to tape or tie the articulating arms together. When he disengaged the tube head, the spring in the articulating arm caused the arm to open and hit the tech in the face causing a laceration with bleeding. The tech was treated and released without incident.
Patient Sequence No: 1, Text Type: D, B5
[19638441]
Conclusion: the incident was directly caused by the svc tech who forgot to tape or tie the articulating arms together. This enabled the articulating arm to open and hit the tech in the face.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1419798-2007-00017 |
| MDR Report Key | 842000 |
| Report Source | 05 |
| Date Received | 2007-04-12 |
| Date of Report | 2007-04-11 |
| Date Mfgr Received | 2007-04-03 |
| Date Added to Maude | 2007-04-30 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | JOHN MILLER, DIR |
| Manufacturer Street | 901 W OAKTON ST |
| Manufacturer City | DES PLAINES IL 60018 |
| Manufacturer Country | US |
| Manufacturer Postal | 60018 |
| Manufacturer Phone | 8473643931 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 770 INTRAORAL X-RAY SYSTEM |
| Generic Name | DIAGNOSTIC X-RAY UNIT |
| Product Code | EAP |
| Date Received | 2007-04-12 |
| Model Number | * |
| Catalog Number | A0771AT |
| Lot Number | * |
| ID Number | * |
| Operator | OTHER |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 829274 |
| Manufacturer | GENDEX IMAGING |
| Manufacturer Address | 901 WEST OAKTON ST DES PLAINES IL 60018 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-04-12 |