MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-03-06 for OMNICYCLE ELITE 000-533 NA manufactured by Medica Medizintechnik Gmbh.
[19922168]
On (b)(6) 2014, pt was pedaling lower extremity on the omnicycle, pt did not want to complete the entire treatment. Protocol reported to have been in "neuro" mode, forward pedaling with no resistance and zero speed. Activity was stopped in the middle of treatment and machine was on pause screen. Therapist assisted the pt in removing her feet from the cycle, unstrapped her, and her left foot got stuck between the left pedal and stabilization bar (t-bar). Pt was in a wheelchair and is reported to have poor control. Wheelchair straps and locks were engaged and the t-bar was not extended as would be expected. Pt was pushing pedal on the opposite side which caused her foot to become wedge and stuck. Therapists could not move the pedal and chose to physically move the cycle to free the pt's foot. Pt rec'd a laceration (4" long) to her lower leg and was taken to the hospital. On (b)(6) 2014 on f/u, assistant dor said the pt rec'd sutures to close the laceration but that she is doing well at this time.
Patient Sequence No: 1, Text Type: D, B5
[20300410]
The lower stabilization bar (t-bar) should be extended when the user places the device in service. There is a card affixed to the t-bar instructing as such when delivered. There is also a section in the user manual covering this topic. They are required to pull the bar out until they see a stop sign, then secure to two set screws with the tool provided. During our investigation it was determined that they had not extended the t-bar. Additionally, when the cycle is in the pause state, the lower extremity will free wheel. If the therapist had rotated the pedal assembly, the pt's foot would not have remained stuck. The laceration was caused when the facility staff forced the movement of the cycle while the pt was still stuck. This caused the lower leg to come in contact with the crank arm which resulted in a skin tear. The pt was transported to the nearest emergency room and rec'd sutures to close the wound. Pt is reported to be doing well.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1911273-2014-00001 |
| MDR Report Key | 3683204 |
| Report Source | 06 |
| Date Received | 2014-03-06 |
| Date of Report | 2014-03-05 |
| Date of Event | 2014-02-13 |
| Date Facility Aware | 2014-02-13 |
| Report Date | 2014-03-05 |
| Date Reported to FDA | 2014-03-06 |
| Date Reported to Mfgr | 2014-03-06 |
| Date Mfgr Received | 2014-03-06 |
| Device Manufacturer Date | 2008-04-01 |
| Date Added to Maude | 2014-03-19 |
| Event Key | 0 |
| Report Source Code | Distributor 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 | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | BLUMENWEG 8 |
| Manufacturer City | HOCHDORF D-88454 |
| Manufacturer Country | GM |
| Manufacturer Postal | D-88454 |
| Manufacturer Phone | 35593140 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OMNICYCLE ELITE |
| Generic Name | EXERCISER, POWERED |
| Product Code | BXB |
| Date Received | 2014-03-06 |
| Returned To Mfg | 2014-03-03 |
| Model Number | 000-533 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | A000533TT008112069 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 6 YR |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDICA MEDIZINTECHNIK GMBH |
| Manufacturer Address | BLUMENWEG 8 HOCKDORF D-88454 GM D-88454 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-03-06 |