MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-06 for RITTER 106-004 manufactured by Midmark Corp.
[119374664]
Patient inadvertently pressed the foot pedal of the ritter 106 electric bed, causing the beds position to move down. Patient was playing on the floor at the time. The bed came down causing the child to become stuck. Upon removal, the patient suffered a laceration to her forehead. Sent to ed for stitches.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7850688 |
| MDR Report Key | 7850688 |
| Date Received | 2018-09-06 |
| Date of Report | 2018-08-08 |
| Date of Event | 2018-07-20 |
| Report Date | 2018-08-08 |
| Date Reported to FDA | 2018-08-08 |
| Date Reported to Mfgr | 2018-09-06 |
| Date Added to Maude | 2018-09-06 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| 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 | 3 |
| Brand Name | RITTER 106-004 |
| Generic Name | CHAIR, SURGICAL, AC-POWERED |
| Product Code | GBB |
| Date Received | 2018-09-06 |
| Model Number | 106-004 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MIDMARK CORP |
| Manufacturer Address | 60 VISTA DRIVE VERSAILLES OH 45380 US 45380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-09-06 |