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

Model Number A000-533

Device Problem Mechanics Altered (2984)

Patient Problems Bone Fracture(s) (1870); Skin Tears (2516)

Event Date 07/16/2014

Event Type  Injury  

Event Description

On (b)(6) 2014 acp was notified of event.Pt was in a wheelchair with her right leg in an extension brace, which needed to be elevated.The therapist removed the right pedal of the omnicycle and placed the pt in front of the cycle to utilize her left side for exercise.Approximately two minutes into the exercise, the pt reported that her leg felt heavy.The therapist noticed blood on the floor.The pt was left unattended.The pt sustained a 5 inch laceration on her right calf which required 18 stitches.

• 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: 4003219
• MDR Text Key: 19590968
• Report Number: 1911273-2014-00003
• 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: 07/29/2014,07/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2014
• 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: A0005330310493088
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/31/2014
• Distributor Facility Aware Date: 07/17/2014
• Device Age: 4 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 07/31/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2010
• 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