MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-10 for MIDMARK 630 HUMANFORM manufactured by Midmark Corp..
[79383458]
Patient Sequence No: 1, Text Type: N, H10
[79383459]
Staff reported: our unit has experienced issues with this specific bed for the last month (controls [foot or hand] not working, stuck in position, etc. ). Today, patient stated that while he and his wife were sitting in the room, the bed began to move into an upright (90 degree angle) position. Patient stated that no one touched or moved the bed or controls. Upon hearing this, medical assistant (ma) attempted to return seat back to normal position but to no avail. Bed would not drop down. We attempted to unplug and reconnect with no success. After a few more attempts, we were able to move the bed into a flat position. Patient stated that he was very uncomfortable and scared of getting back on the bed should it start moving on its own during his rectal ultrasound. We unplugged the bed, and the patient carried on with his procedure. The bed remains unplugged as we are not certain of its dependability. Clinical engineering report: replaced batteries in foot control. Re-associated foot control with exam table. Removed rear cover exposing main pc board. Found error codes to be displayed. Removed power from exam table. Adjusted s2 dip switches to the on position. Supplied power and displayed error codes. Based off of error codes, checked fuses f1 thru f5. Fuses check good. Cleared error codes. Re-ran error code diagnostics. Found error code to display 01 15: "rotation locked out". Found connector j12 to be removed. Reinstalled connector. Resupplied power. All functions work with hand and foot control. Will continue to monitor. User reported experiencing more phantom movement. Will continue to troubleshoot. Removed rear cover, exposing main pc board. No error codes on display. All fuses check good. No loose, broken or frayed wires or connectors. Called midmark tech support. They will be sending a new set of hand and foot controls for troubleshooting. Manufacturer response for table, exam/treatment, powered, midmark 630 human form (per site reporter).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6696476 |
| MDR Report Key | 6696476 |
| Date Received | 2017-07-10 |
| Date of Report | 2017-07-05 |
| Date of Event | 2017-06-23 |
| Report Date | 2017-07-03 |
| Date Reported to FDA | 2017-07-03 |
| Date Reported to Mfgr | 2017-07-03 |
| Date Added to Maude | 2017-07-10 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| 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 | MIDMARK 630 HUMANFORM |
| Generic Name | AC POWERED CHAIR, SURGICAL |
| Product Code | FNK |
| Date Received | 2017-07-10 |
| Model Number | 630 |
| Device Availability | * |
| Device Age | 3 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | MIDMARK CORP. |
| Manufacturer Address | 60 VISTA DR. VERSAILLES OH 45380 US 45380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-07-10 |