MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY E-Z LIFT BEACH CHAIR; POWERED BEACH CHAIR

Model Number	800-0142
Medical Device Problem Code	Device Fell (4014)
Health Effect - Clinical Code	Fall (1848)
Date of Event	04/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during a patient procedure their non-steris e-z lift beach chair which was attached to a steris surgical table fell backwards resulting in a procedure delay and injury to the patient's neck.It is unknow if medical treatment was sought or administered.
Additional Manufacturer Narrative
Steris evaluated the reported event and determined it meets our reporting criteria under 21 cfr part 803; however, steris is not the manufacturer of the e-z lift beach chair.Steris notified the manufacturer, schuremed, of the reported event to internally investigate and evaluate for reportability in accordance with 21 cfr part 803.The device subject of the reported event was returned to steris for a full analysis.A follow-up mdr will be submitted when additional information becomes available.
Additional Manufacturer Narrative
The device was returned for evaluation.Schuremed's evaluation determined that the slide extenders required to be replaced due to the damage that was caused by mis-clamping the chair to the table by user facility personnel.A steris sales representative provided in-service training to the user facility on properly attaching the chair to the table according to the ifu to prevent any damage.No additional issues have been reported.

• Brand Name: E-Z LIFT BEACH CHAIR
• Common Device Name: POWERED BEACH CHAIR
• Manufacturer (Section D): STERIS CORPORATION - MONTGOMERY; 2720 gunter park drive east; montgomery AL 36109
• Manufacturer (Section G): STERIS CORPORATION - MONTGOMERY; 2720 gunter park drive east; montgomery AL 36109
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060
• MDR Report Key: 16948196
• Report Number: 1043572-2023-00102
• Device Sequence Number: 6423520
• Product Code: GBB
• UDI-Device Identifier: 00810014601885
• UDI-Public: 00810014601885
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 800-0142
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2023
• Supplement Date Received by Manufacturer: 04/20/2023
• Initial Report FDA Received Date: 05/17/2023
• Supplement Report FDA Received Date: 06/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown