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	Laceration(s) (1946)
Date of Event	02/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the harmonyair monitor carrier and found the unit to be operating according to specification.No repairs were required, and the unit was returned to service.A steris account manager was informed of the reported event and stated that the procedure room is compact with low ceilings.It is likely that due to the lack of space, employees may have inadvertently bumped the spring arm into other pieces of equipment or other objects in the room resulting in the end cover detachment.The harmonyair monitor carrier operator manual states (1), "warning - personal injury and/or equipment damage hazard: use of this equipment adjacent to other equipment should be avoided due to risk of improper operation of the powered device.Observe equipment used adjacent to this equipment for proper operation prior to use." the account manager counseled user facility personnel on the proper use and operation of the harmonyair monitor carrier specifically on the importance of not bumping the unit into other pieces of equipment in the room.A three-year complaint review indicates this to be an isolated event.No additional issues have been reported.
Event or Problem Description
The user facility reported that during a patient procedure the end cover to their harmonyair monitor carrier detached from the spring arm, making contact with the side of an employee's face, resulting in an injury (laceration).Medical treatment was sought and administered.No report of procedure delay.

• 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 ; 4403927453
• MDR Report Key: 16466731
• Report Number: 1043572-2023-00054
• Device Sequence Number: 7774835
• Product Code: FQO
• UDI-Device Identifier: 00724995153380
• UDI-Public: 00724995153380
• 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): 03/02/2023

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: Monitor Carrier
• Device Catalogue Number: HCLP120004
• 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: 02/02/2023
• Initial Report FDA Received Date: 03/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2022
• 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