MAUDE Adverse Event Report: MAQUET GMBH MAQUET SURGICAL TABLE; TABLE, OPERATING-ROOM, AC-POWERED

Model Number 1180.01B2

Device Problems Mechanical Problem (1384); Device Displays Incorrect Message (2591)

Patient Problem Insufficient Information (4580)

Event Date 06/20/2022

Event Type  malfunction  

Event Description

Table functioning prior to patient entering the operating room.Following patient positioning, a "align joint surfaces" error was displayed.The table became inoperable.Maquet service called.Fda safety report id # (b)(4).

• Brand Name: MAQUET SURGICAL TABLE
• Type of Device: TABLE, OPERATING-ROOM, AC-POWERED
• Manufacturer (Section D): MAQUET GMBH
• MDR Report Key: 14788231
• MDR Text Key: 294671403
• Report Number: MW5110465
• 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: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1180.01B2
• Device Catalogue Number: 1180.01B2
• 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: 80 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White