MAUDE Adverse Event Report: BERCHTOLD GMBH & CO. KG OPERON D 860 O. R. TABLE; TABLE, OPERATING-ROOM, ELECTRICAL

Device Problems Use of Device Problem (1670); Key or Button Unresponsive/not Working (4063)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/07/2022

Event Type  malfunction  

Event Description

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).

• Brand Name: OPERON D 860 O. R. TABLE
• Type of Device: TABLE, OPERATING-ROOM, ELECTRICAL
• Manufacturer (Section D): BERCHTOLD GMBH & CO. KG
• MDR Report Key: 15673372
• MDR Text Key: 302493648
• Report Number: MW5112839
• Device Sequence Number: 1
• Product Code: GDC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2022
• 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Weight: 89 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American