MAUDE Adverse Event Report: MIZUHO OSI CHEST SUPPORT TRAY

Model Number	5840-580
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2021
Type of Reportable Event	Malfunction
Event or Problem Description
During pre/post-procedure inspection, the chest tray was found to have a crack.Unknown how or when the crack happened, but there is suspicion it might have been when the previous patient was on the table.
Event or Problem Description
During pre/post-procedure inspection, the chest tray was found to have a crack.Unknown how or when the crack happened, but there is suspicion it might have been when the previous patient was on the table.
Additional Manufacturer Narrative
One image was provided, there was a crack on one of the ends of the 5840-580, however, there are also markings on the corner where the chest support plate is cracked.The markings could be an indication that the 5840-580 chest support plate had been previously dropped or banged, creating the crack.As indicated by account manager, "chest support plate was found broken sometime after patient use, it is not clear if this happened before/during/after patient transfer".

• Brand Name: CHEST SUPPORT TRAY
• Common Device Name: CHEST SUPPORT TRAY
• Manufacturer (Section D): MIZUHO OSI; 30031 ahern av; union city CA 94587 1234
• Manufacturer (Section G): MIZUHO OSI; 30031 ahern av; union city CA 94587 1234
• Manufacturer Contact: krina shah ; 30031 ahern avenue; union city, CA 94587-1234 ; 5104291500
• MDR Report Key: 12801195
• Report Number: 2921578-2021-00023
• Device Sequence Number: 4756845
• Product Code: JEA
• UDI-Device Identifier: 00842430104343
• UDI-Public: 00842430104343
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2022

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: 5840-580
• Device Catalogue Number: 5840-580
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2021
• Supplement Date Received by Manufacturer: 10/29/2021
• Initial Report FDA Received Date: 11/11/2021
• Supplement Report FDA Received Date: 01/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2020
• 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