MAUDE Adverse Event Report: MAQUET GMBH MAQUET O.R. TABLE SYSTEM MAGNUS; FQO & KXJ-TABLE,AC POWERED & RADIOLOGIC

Model Number 1180.01B1

Device Problems Device Operates Differently Than Expected (2913); Positioning Problem (3009)

Patient Problems Death (1802); No Information (3190)

Event Type  Death  

Event Description

Customer reported to maquet that they are dissatisfied with the image quality and system controls of the maquet magnus hybrid table system installed at their hospital.Maquet agreed to remove the magnus table system from the hospital as it did not meet their needs.During the conversation outlining the removal plan; a hospital rep informed maquet that there was a death in the room containing the magnus table.The customer did not directly indicate if the alleged death was attributed to the magnus device.Only the height and weight data of the pt was reported to maquet.Height 5'10" and weight 210 pounds.(b)(4).Ref mfr # 80100652-2014-00007.

• Brand Name: MAQUET O.R. TABLE SYSTEM MAGNUS
• Type of Device: FQO & KXJ-TABLE,AC POWERED & RADIOLOGIC
• Manufacturer (Section D): MAQUET GMBH; kehler strasse 31; rastatt 7643 7; GM 76437
• Manufacturer (Section G): MAQUET MEDICAL SYSTEMS USA; 45 barbour pond drive; wayne NJ 07470 000
• Manufacturer Contact: 45 barbour pond drive; wayne, NJ 07470-0000
• MDR Report Key: 3721987
• MDR Text Key: 4276918
• Report Number: 3008355164-2014-00069
• Device Sequence Number: 1
• Product Code: FQO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/25/2014,02/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1180.01B1
• Device Catalogue Number: 1180.01B1
• Other Device ID Number: 1180.16F2 SERIAL 12
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/24/2014
• Device Age: 17 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/26/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Weight: 95