MAUDE Adverse Event Report: MEDICA MEDIZINTECHNIK GMBH OMNICYCLE ELITE; EXERCISER, POWERED

Model Number 000-533

Device Problem Mechanics Altered (2984)

Patient Problem Skin Tears (2516)

Event Date 02/13/2014

Event Type  Injury  

Event Description

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.

Manufacturer Narrative

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.

• Brand Name: OMNICYCLE ELITE
• Type of Device: EXERCISER, POWERED
• Manufacturer (Section D): MEDICA MEDIZINTECHNIK GMBH; blumenweg 8; hockdorf D-88 454; GM D-88454
• Manufacturer Contact: blumenweg 8; hochdorf D-884-54 ; 35593140
• MDR Report Key: 3683204
• MDR Text Key: 19922168
• Report Number: 1911273-2014-00001
• Device Sequence Number: 1
• Product Code: BXB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 000-533
• Other Device ID Number: A000533TT008112069
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/03/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/06/2014
• Distributor Facility Aware Date: 02/13/2014
• Device Age: 6 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 03/06/2014
• Date Manufacturer Received: 03/06/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention