MAUDE Adverse Event Report: MIDMARK CORP RITTER EXAM TABLE 204; DEVICE, MEDICAL EXAMINATION, AC POWERED

Model Number 204-002

Device Problem Unintended Movement (3026)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 06/16/2016

Event Type  Injury  

Event Description

The footstep was extended so the pt could get upon the exam table.There was a little sway in the footstep and the patient's left foot slipped off the edge.He fell down to the floor.An ambulance was called.He was transported to the hospital.Ed evaluation confirms left ankle fracture, which was casted.

• Brand Name: RITTER EXAM TABLE 204
• Type of Device: DEVICE, MEDICAL EXAMINATION, AC POWERED
• Manufacturer (Section D): MIDMARK CORP; 60 vista drive; versailles OH 45380
• MDR Report Key: 5878186
• MDR Text Key: 52167897
• Report Number: 5878186
• Device Sequence Number: 1
• Product Code: KZF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/28/2016,08/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 204-002
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/28/2016
• Device Age: 4 YR
• Date Report to Manufacturer: 07/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO OTHER THERAPIES
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 65 YR
• Patient Weight: 136