MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-01 for NOT DETERMINED manufactured by Invivo Corporation.
[53782214]
The investigation of this event is ongoing, final investigation results will be communicated at a later date.
Patient Sequence No: 1, Text Type: N, H10
[53782215]
A ge healthcare fse was moving a sentinelle table when his hand had become wedged between the table handle and the door frame. The door frame happen to have shard edges causing an incision in his hand which required stitches to correct.
Patient Sequence No: 1, Text Type: D, B5
[62732906]
The service fsr was moving a vanguard table out of an mr room when his hand became caught between the table and the mr room door frame. User guides for vanguard tables reference that there is a risk to operator injury. The warning states? Keep limbs away from the gap between the tabletop and the scanner while raising and lowering the mr patient table.? The same principle would apply when moving the table, i. E limbs should be kept away from the gap between the tabletop and other surfaces. Due to the weight of the table, it should be manipulated slowly to avoid it swinging. Ge communicated the incident to their field engineers to be aware of the potential for injury if a body part is caught between the table and mr room door frame. This is the first complaint for this type is failure; therefore, no design change is warranted at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1056069-2016-00002 |
| MDR Report Key | 5923022 |
| Date Received | 2016-09-01 |
| Date of Report | 2016-08-19 |
| Date Mfgr Received | 2016-08-02 |
| Date Added to Maude | 2016-09-01 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. KENNETH REVENNAUGH |
| Manufacturer Street | 3545 SW 47TH AVE |
| Manufacturer City | GAINSVILLE FL 32608 |
| Manufacturer Country | US |
| Manufacturer Postal | 32608 |
| Manufacturer G1 | PHILIPS HEALTHCARE - INVIVO DIAGNOSTIC IMAGING |
| Manufacturer Street | 3545 SW 47TH AVE |
| Manufacturer City | GAINESVILLE FL 32608 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32608 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | NOT DETERMINED |
| Product Code | MOS |
| Date Received | 2016-09-01 |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INVIVO CORPORATION |
| Manufacturer Address | 3545 SW 47TH AVE GAINSVILLE FL 32608 US 32608 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-09-01 |