MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-01 for PERFORMA BAR ACTIVATED 2-SECTION BOBATH TABLE 081502236 manufactured by Patterson Medical Companies Inc.
[24663636]
Patient Sequence No: 1, Text Type: N, H10
[24663637]
An occupational therapy patient was sitting on a chair next to the hi-lo table. He placed his foot on the lever that lowers the treatment table. The table began lowering. The occupational therapists saw the table lowering towards the patient's leg and told the patient to take his foot off of the lever. The patient did not respond (he is s/p cva and this may have contributed towards his not responding or noticing the table was lowering). The table lowered onto the patient's knee and continued to lower (as the patient's foot was still depressing the bar). His leg became entrapped and there was an audible cracking sound. The occupational therapist sprained her wrists freeing the patient's leg. The device does not detect an obstruction in the movement path when it is engaged. So long as the lever is depressed, the device will complete its movement path to the manufacturer's preset endpoint regardless of obstruction. The patient was ultimately brought via ambulance to another hospital. Reportedly, he was found to have a fractured ankle. During our investigation, we have noted that we recently purchased a second table from the same manufacturer. The table involved in this matter lowers when the lever is depressed and rises when the lever is lifted. The other table operates in the opposite fashion (lowers when the lever is raised and rises when the lever is depressed).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5044606 |
| MDR Report Key | 5044606 |
| Date Received | 2015-09-01 |
| Date of Report | 2015-08-28 |
| Date of Event | 2015-08-20 |
| Report Date | 2015-08-28 |
| Date Reported to FDA | 2015-08-28 |
| Date Reported to Mfgr | 2015-08-28 |
| Date Added to Maude | 2015-09-01 |
| 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 | 0 |
| 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 | 3 |
| Brand Name | PERFORMA BAR ACTIVATED 2-SECTION BOBATH TABLE |
| Generic Name | TABLE, POWERED |
| Product Code | INQ |
| Date Received | 2015-09-01 |
| Model Number | 081502236 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | 3 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PATTERSON MEDICAL COMPANIES INC |
| Manufacturer Address | 1031 MENDOTA HEIGHTS RD SAINT PAUL MN 55120 US 55120 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-09-01 |