MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY HARMONY EMS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Laceration(s) (1946)

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite to inspect the harmony ems and found that the covers for the end of the boom rails were missing.The missing covers allowed the employee to contact the edge of the boom rail resulting in the reported event.Through discussion with user facility personnel, the technician learned that the customer is using the rails to wrap cabling around and as the cabling is unwrapped the covers are detaching.User facility personnel were aware that the covers were missing and continued use of the harmony ems boom.The user facility did not contact steris prior to the reported event for service.The harmony ems operator manual states (6-1), "important: if it important: appears that service may be required to return this equipment to top operating condition, engage a qualified service technician to perform any repairs." the technician reattached the covers, tested the unit, confirmed it to be operating according to specification, and returned it to service.No additional issues have been reported.

Event Description

The user facility reported that several employees have been injured by their harmony ems boom.It was reported that one employee obtained a cut on her arm and received medical treatment.

• Brand Name: HARMONY EMS
• Type of Device: HARMONY EMS
• Manufacturer (Section D): STERIS CORPORATION - MONTGOMERY; 2720 gunter park drive east; montgomery, al
• Manufacturer (Section G): STERIS CORPORATION - MONTGOMERY; 2720 gunter park drive east; montgomery, al
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, oh ; 3927453
• MDR Report Key: 10260909
• MDR Text Key: 202422817
• Report Number: 1043572-2020-00031
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/11/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1