MAUDE Adverse Event Report: SCIFIT SYSTEMS, INC. ISO1000 EXERCISE BICYCLE; EXERCISER, NON-MEASURING

Model Number ISO1000 R

Device Problems Detachment Of Device Component (1104); Device Slipped (1584)

Patient Problem No Information (3190)

Event Date 04/16/2014

Event Type  malfunction  

Event Description

Gear would not engage.Pedals moved with no resistance.Evaluated by biomed: drive belt came off, replaced belt and adjusted bike tension.Function test completed and passed.Bike back in service.

• Brand Name: ISO1000 EXERCISE BICYCLE
• Type of Device: EXERCISER, NON-MEASURING
• Manufacturer (Section D): SCIFIT SYSTEMS, INC.; 5151 south 110th east ave.; tulsa OK 74146
• MDR Report Key: 4143278
• MDR Text Key: 4766651
• Report Number: 4143278
• Device Sequence Number: 1
• Product Code: ION
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 09/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Patient
• Device Model Number: ISO1000 R
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/26/2014
• Device Age: 5 YR
• Date Report to Manufacturer: 10/06/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NO OTHER THERAPIES