MAUDE Adverse Event Report: BERCHTOLD GMBH & CO. KG OPERON D860 SEAT,CFK,STAINLESS,POWERDRV; TABLE, OPERATING-ROOM, ELECTRICAL

Model Number	OT 8602165
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after procedure started, when putting patient in reverse trendelenburg, the bed malfunctioned, and the control command button failed to work properly.Patient was transferred to another bed to finish procedure.No harm to patient.Bed removed from service.There were no reported adverse consequences due to the delay or any reported patient injury.
Additional Manufacturer Narrative
It was reported that after procedure started, when putting patient in reverse trendelenburg, the bed malfunctioned, and the control command button failed to work properly.Patient was transferred to another bed to finish procedure.No harm to patient.Bed removed from service.Since there was a delay in procedure and that the patient had to be transferred to another bed with possibility that this occurred while there was organ exposure, a conservative malfunction will be filed.If any further information is received, a supplemental will be filed.
Event or Problem Description
It was reported that after procedure started, when putting patient in reverse trendelenburg, the bed malfunctioned, and the control command button failed to work properly.Patient was transferred to another bed to finish procedure.No harm to patient.Bed removed from service.There were no reported adverse consequences due to the delay or any reported patient injury.
Additional Manufacturer Narrative
It was reported by the customer that on (b)(6) 2022 that "after procedure started, when putting patient in reverse trendelenburg, bed malfunctioned and control command button failed to work properly.Pt transferred to another bed to finish procedure.No harm to patient.Bed removed from service.Vendor contacted to evaluate and repair.Fda safety report id# (b)(4).".The customer ordered a new hand pendant for the table and completed the repair in house.There was reported patient involvement but no report of patient injury or adverse event.Manufacture date is not known.
Event or Problem Description
It was reported that after procedure started, when putting patient in reverse trendelenburg, the bed malfunctioned, and the control command button failed to work properly.Patient was transferred to another bed to finish procedure.No harm to patient.Bed removed from service.There were no reported adverse consequences due to the delay or any reported patient injury.Please note the initial report was determined when it was currently unknown whether or not there was organ exposure when the issue occurred and so a conservative malfunction was filed.However, per additional information received, it has been confirmed that there was no organ exposure when this issue occurred.Therefore making this event not reportable.
Additional Manufacturer Narrative
It was reported by the customer that on (b)(6) 2022 that "after procedure started, when putting patient in reverse trendelenburg, bed malfunctioned and control command button failed to work properly.Pt transferred to another bed to finish procedure.No harm to patient.Bed removed from service.Vendor contacted to evaluate and repair.Fda safety report id# (b)(4).".The customer ordered a new hand pendant for the table and completed the repair in house.There was reported patient involvement but no report of patient injury or adverse event.Please note the initial report was determined when it was currently unknown whether or not there was organ exposure when the issue occurred and so a conservative malfunction was filed.However, per additional information received, it has been confirmed that there was no organ exposure when this issue occurred.Therefore making this event not reportable.Manufacture date is not known.H3 other text : 81.

• Brand Name: OPERON D860 SEAT,CFK,STAINLESS,POWERDRV
• Common Device Name: TABLE, OPERATING-ROOM, ELECTRICAL
• Manufacturer (Section D): BERCHTOLD GMBH & CO. KG; ludwigstaler strasse 25; tuttlingen CA 78532 ; GM 78532
• Manufacturer (Section G): BERCHTOLD GMBH & CO. KG; ludwigstaler strasse 25; tuttlingen CA 78532 ; GM 78532
• Manufacturer Contact: volker hornscheidt ; ludwigstaler strasse 25; tuttlingen, CA 78532 ; GM 78532 ; 4087542000
• MDR Report Key: 15889876
• Report Number: 0008010153-2022-00011
• Device Sequence Number: 17514389
• Product Code: GDC
• UDI-Device Identifier: 07613327170122
• UDI-Public: 07613327170122
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/23/2023

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
• Device Model Number: OT 8602165
• Device Catalogue Number: OT 8602165
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/31/2022
• Supplement Date Received by Manufacturer: 10/31/2022; 10/31/2022
• Initial Report FDA Received Date: 11/30/2022
• Supplement Report FDA Received Date: 02/04/2023; 05/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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