MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-25 for SONESTA 6202 SERIES IMAGING TABLE manufactured by Sonesta Medical Ab.
[106791534]
The bolt that holds the motor that powers the table to move up and down at the back of the table came out and the table teetered forward and the patient fell to the ground. Device arrived new to hospital on (b)(6) 2008.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5076782 |
| MDR Report Key | 7464544 |
| Date Received | 2018-04-25 |
| Date of Report | 2018-04-03 |
| Date of Event | 2018-04-03 |
| Date Added to Maude | 2018-04-26 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SONESTA 6202 SERIES IMAGING TABLE |
| Generic Name | TABLE, RADIOGRAPHIC, TILTING |
| Product Code | IXR |
| Date Received | 2018-04-25 |
| Model Number | 6202 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | SONESTA MEDICAL AB |
| Brand Name | SONESTA 6202 SERIES IMAGING TABLE |
| Generic Name | TABLE, RADIOGRAPHIC, TILTING |
| Product Code | IXR |
| Date Received | 2018-04-25 |
| Model Number | 6202 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STILLE AB |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-25 |