MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY HARMONYAIR MONITOR CARRIER

Model Number	Monitor Carrier
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician inspected the harmonyair monitor carrier and found that the over-rotation of the lower and upper boom arms caused them to impact one another subsequently dislodging a plastic bearing cover upon impact.The steris technician resecured the plastic bearing cover, tested the unit and confirmed it to be operational.The operator manual states (pg.12), "avoid damage to equipment by articulating (do not approach stops roughly; avoid collisions with other equipment) the equipment slowly and evenly." the steris technician counseled user facility personnel on the importance of using caution when moving the boom arms.The harmonyair monitor carrier was returned to service and no additional issues have been reported.
Event or Problem Description
The user facility reported that while an employee was moving the harmonyair monitor carrier, the lower boom arm bumped into the upper boom arm subsequently dislodging a plastic bearing cover and contacting the patient's shin.No report of injury.

• Brand Name: HARMONYAIR MONITOR CARRIER
• Common Device Name: MONITOR CARRIER
• 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: 17086187
• Report Number: 1043572-2023-00112
• Device Sequence Number: 16852590
• Product Code: FQO
• UDI-Device Identifier: 00724995153663
• UDI-Public: 00724995153663
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: Monitor Carrier
• Device Catalogue Number: HCES160005
• 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: 05/12/2023
• Initial Report FDA Received Date: 06/08/2023
• 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