MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-18 for EOS RADIOLUCENT CHAIR 9000113040 manufactured by Eos Imaging.
[87602329]
On (b)(6) 2017, (b)(4), eos imaging regional application specialist, received a call from (b)(6), director of radiology at (b)(6). It was initially reported that while moving a patient seated in an eos radiolucent chair into the eos system gantry the chair flipped over backwards. Fortunately, they had 2 staff members in the room and the patient was not injured. Additional information was requested by (b)(4) and received the same day from (b)(6), it was reported the following: the patient was strapped into the chair when this happened. They were attempting to push the patient up the ramp and into the gantry. The rear wheels got caught on the entry ramp which caused the chair to tip over. Patient's family was in the eos room at the time. The onsite physician and nurses examined the patient and no physical injuries were noticed. There were 3 technologists attempting to move the patient into the gantry with one at either side and the other at the front of the chair. The chair fell completely over and into the gantry. They managed to get the chair upright and the patient was removed from the room. Patient details are as follows: age-(b)(6). Gender- male. Weight- (b)(6). Height-154. 9 cm. Patient is also wheelchair bound.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006165260-2017-00002 |
| MDR Report Key | 6872886 |
| Date Received | 2017-09-18 |
| Date of Event | 2017-08-17 |
| Date Mfgr Received | 2017-08-17 |
| Device Manufacturer Date | 2017-04-11 |
| Date Added to Maude | 2017-09-18 |
| 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 | RADIOLOGIC TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR BERNARD ISMAEL |
| Manufacturer Street | 10 RUE MERCOEUR |
| Manufacturer City | PARIS, PARIS 75011 |
| Manufacturer Country | FR |
| Manufacturer Postal | 75011 |
| Manufacturer G1 | EOS IMAGING |
| Manufacturer Street | 10 RUE MERCOEUR |
| Manufacturer City | PARIS, PARIS 75011 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 75011 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | EOS RADIOLUCENT CHAIR |
| Generic Name | RADIOLUCENT CHAIR |
| Product Code | INM |
| Date Received | 2017-09-18 |
| Model Number | EOS RADIOLUCENT CHAIR |
| Catalog Number | 9000113040 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EOS IMAGING |
| Manufacturer Address | 10 RUE MERCOEUR PARIS, PARIS 75011 FR 75011 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-09-18 |