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

Model Number A000-533

Device Problem Mechanics Altered (2984)

Patient Problem Bone Fracture(s) (1870)

Event Date 05/12/2014

Event Type  No Answer Provided  

Event Description

Patient was pedaling using lower extremity exerciser on the omnicycle.Patient's left pant leg got caught in crank arm which twisted pants around patient's leg.No one had noticed the pants being twisted around patient's leg until the patient cried out.Therapist then pushed the stop button to stop session.Patient incurred bruising and after continued swelling, and was sent for x-ray.The first viewing of x-ray was reported as an old fracture anterior tibia, second viewing of x-ray was reported as a new fracture.Patient has diagnosis history of osteoporosis.

Manufacturer Narrative

On (b)(6) 2014 accelerated care plus (distributor) staff took pictures of the omnicycle after the event.The cycle's left and right side calf support and velcro straps were not attached, and the right side calf support bar was detached from foot pedal.The first viewing of x-ray was reported as an old fracture anterior tibia, second viewing of x-ray was reported as a new fracture.The patient is confirmed as having existing osteoporosis.

• 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; hockdorf D-884-54 ; 35593140
• MDR Report Key: 3879533
• MDR Text Key: 4569893
• Report Number: 1911273-2014-00002
• Device Sequence Number: 1
• Product Code: BXB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXCEPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: User Facility
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 05/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: A000-533
• Other Device ID Number: A0005330311131064
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/19/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/16/2014
• Device Age: 3 YR
• Event Location: Nursing Home
• Date Manufacturer Received: 05/16/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention