MAUDE Adverse Event Report: STERIS CORPORATION HARMONYAIR; HARMONYAIR M-SERIES SUSPENSION

Model Number	M-SERIES SUSPENSION
Medical Device Problem Codes	Unintended Movement (3026); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Head Injury (1879)
Date of Event	07/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The harmony air m-series suspension subject of the reported event is approximately 6 years old.Steris does not perform routine preventive maintenance on the system; it is unknown who services and maintains the device.The steris service technician contacted the user facility multiple times to obtain additional information regarding the reported event.User facility personnel stated they are conducting an internal investigation and has not given steris access to the device for inspection or evaluation.A follow-up report will be submitted should additional information become available.
Event or Problem Description
The user facility reported that the connect point from their harmony air m-series suspension "fell" and hit an employee in the head.The employee was sent to the er.It is unknown if the employee received medical treatment at the er.
Additional Manufacturer Narrative
User facility personnel confirmed that the harmonyair m-series suspension did not fall, but instead drifted down during a procedure and contacted an employee's head.A steris service technician inspected the harmonyair m-series suspension and found that the brake assembly was worn and required repair.The technician repaired the unit, tested the function and operation of the device, confirmed it to be operating to specifications, and returned it to service.The steris service technician counseled user facility personnel on the importance of performing routine preventive maintenance for their harmonyair m-series suspension.No additional issues have been reported.

• Brand Name: HARMONYAIR
• Common Device Name: HARMONYAIR M-SERIES SUSPENSION
• Manufacturer (Section D): STERIS CORPORATION; 2720 gunter park drive east; montgomery AL 36109
• Manufacturer (Section G): STERIS CORPORATION; 2720 gunter park drive east; montgomery AL 36109
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060
• MDR Report Key: 19951345
• Report Number: 1043572-2024-00056
• Device Sequence Number: 13003594
• Product Code: FQO
• UDI-Device Identifier: 00724995161385
• UDI-Public: (01)00724995161385(11)180205
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 08/09/2024

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: M-SERIES SUSPENSION
• Device Catalogue Number: LM99API
• 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: 07/11/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/09/2024
• Supplement Report FDA Received Date: 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/05/2018
• 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