MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-04-01 for PLANMECA PROONE FE001583 manufactured by Planmeca Oy.
[41611809]
Investigative actions: the event had been stored on video from a security camera near the product. This showed clearly that an extra chair had been left to block the movement of the panoramic c-arm, and that this chair was removed after jamming the downward movement. The support wires, which normally are tight and holds up the c-arm were thus driven a bit loose and the c-arm dropped down as the obstacle was removed. Technicians from our company and dealer visited the customer and checked the product and its functions - all was as it should be. User manual includes following note, which had not been followed: when positioning seated patients (e. G. In a wheelchair) always first move the c-arm down until the patient support is approximately level with the patient's mouth before you position the patient in the x-ray unit. Root cause of problem: the event was caused by an incorrectly placed chair in the imaging area. Main cause is negligence by user.
Patient Sequence No: 1, Text Type: N, H10
[41611810]
The dental panoramic x-ray unit planmeca proone was used for imaging a sitting child patient. When the unit was driven down, the imaging head was driven against an extra chair in the imaging room. The dentist then observed the chair and pulled it away, with the consequence that the whole x-ray imaging head part dropped down a bit (maybe two inches). No one was hurt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030876-2016-00001 |
| MDR Report Key | 5540478 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-04-01 |
| Date of Report | 2016-03-17 |
| Date of Event | 2016-02-20 |
| Date Mfgr Received | 2016-02-25 |
| Device Manufacturer Date | 2012-02-27 |
| Date Added to Maude | 2016-04-01 |
| 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 | MR. LARS MORING |
| Manufacturer Street | ASENTAJANKATU 6 |
| Manufacturer City | HELSINKI, 00880 |
| Manufacturer Country | FI |
| Manufacturer Postal | 00880 |
| Manufacturer Phone | 20 7795586 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PLANMECA PROONE |
| Generic Name | PLANMECA PROONE |
| Product Code | MUH |
| Date Received | 2016-04-01 |
| Model Number | FE001583 |
| Operator | DENTIST |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PLANMECA OY |
| Manufacturer Address | ASENTAJANKATU 6 HELSINKI, 020 7795 555 00880 FI 00880 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-04-01 |