MAUDE Adverse Event Report: PERFORMANCE HEALTH INTERNATIONAL LTD THERASLIDE RAIL SYSTEM; EXERCISER, NON-MEASURING

Model Number 081053412

Device Problems Break (1069); Loose or Intermittent Connection (1371)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 08/09/2023

Event Type  Injury  

Event Description

Patient was using a wall-mounted resistance band for exercises.The band is attached to a metal bracket that is fixed to a sliding rail to adjust its height.The metal bracket broke off the rail when he pulled on the band and hit him on the top of his head.The patient began bleeding from a small gash, and staff applied pressure to the wound, had him sit down, and applied ice.He was monitored closely and did not lose consciousness and did not feel dizzy at any point.Bleeding was controlled via compression.Vitals were taken and patient was stable and responsive when wheeled to the ed.Our facilities staff installed the equipment in [redacted date].It was received in [redacted date].No deviation in practice from mifu.There is a screw proximal to the rail that is supposed to remain tight.It is believed that over time, the screw got loose.Perhaps it is too short for metal clamp.When patient was pulling on the band and over time, the clamp came apart.The screw in another practice setting was re-secured with a screwdriver, but this is not a routine practice requirement.The patient was on anticoagulants and therefore bled more than the average person.Device being sent to risk management; our health system will not return this to the manufacturer for investigation.Our value analysis nurse is contacting the rep for discussion.Manufacturer response for physical therapy band system, theraslide rail system (per site reporter) site notified vendor, corporate supply chain reaching out as of [redacted date].

Event Description

Patient was using a wall-mounted resistance band for exercises.The band is attached to a metal bracket that is fixed to a sliding rail to adjust its height.The metal bracket broke off the rail when he pulled on the band and hit him on the top of his head.The patient began bleeding from a small gash, and staff applied pressure to the wound, had him sit down, and applied ice.He was monitored closely and did not lose consciousness and did not feel dizzy at any point.Bleeding was controlled via compression.Vitals were taken and patient was stable and responsive when wheeled to the ed.Our facilities staff installed the equipment in [redacted date].It was received in [redacted date].No deviation in practice from mifu.There is a screw proximal to the rail that is supposed to remain tight.It is believed that over time, the screw got loose.Perhaps it is too short for metal clamp.When patient was pulling on the band and over time, the clamp came apart.The screw in another practice setting was re-secured with a screwdriver, but this is not a routine practice requirement.The patient was on anticoagulants and therefore bled more than the average person.Device being sent to risk management; our health system will not return this to the manufacturer for investigation.Our value analysis nurse is contacting the rep for discussion.Manufacturer response for physical therapy band system, theraslide rail system (per site reporter): site notified vendor, corporate supply chain reaching out as of [redacted date].

Event Description

Patient was using a wall-mounted resistance band for exercises.The band is attached to a metal bracket that is fixed to a sliding rail to adjust its height.The metal bracket broke off the rail when he pulled on the band and hit him on the top of his head.The patient began bleeding from a small gash, and staff applied pressure to the wound, had him sit down, and applied ice.He was monitored closely and did not lose consciousness and did not feel dizzy at any point.Bleeding was controlled via compression.Vitals were taken and patient was stable and responsive when wheeled to the emergency department.Our facilities staff installed the equipment in [redacted date].It was received in [redacted date].No deviation in practice from mifu.There is a screw proximal to the rail that is supposed to remain tight.It is believed that over time, the screw got loose.Perhaps it is too short for metal clamp.When patient was pulling on the band and over time, the clamp came apart.The screw in another practice setting was re-secured with a screwdriver, but this is not a routine practice requirement.The patient was on anticoagulants and therefore bled more than the average person.Device being sent to risk management; our health system will not return this to the manufacturer for investigation.Our value analysis nurse is contacting the rep for discussion.Manufacturer response for physical therapy band system, theraslide rail system (per site reporter): site notified vendor, corporate supply chain reaching out as of [redacted date].

• Brand Name: THERASLIDE RAIL SYSTEM
• Type of Device: EXERCISER, NON-MEASURING
• Manufacturer (Section D): PERFORMANCE HEALTH INTERNATIONAL LTD; 28100 torch parkway; warrenville IL 60555
• MDR Report Key: 17649768
• MDR Text Key: 322268137
• Report Number: 17649768
• Device Sequence Number: 1
• Product Code: ION
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 08/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 081053412
• 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: 08/10/2023
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 08/30/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male