MAUDE Adverse Event Report: HOLGER ULLRICH MAGNUS OR-TABLE COLUMN, INDEPEN; TABLE, OPERATING-ROOM, AC-POWERED

Model Number 118001D0

Device Problems Use of Device Problem (1670); Insufficient Information (3190)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/07/2020

Event Type  malfunction  

Manufacturer Narrative

At the time of this report the investigation is still ongoing.As soon as the investigation is finished the report will be updated and a follow-up/final report will be provided.Getinge-maquet gmbh provides product failure investigation, analysis, and resolution for the device described in this report.

Event Description

The following was reported.During a surgery the table did not move.A warning was shown on the remote control.The surgery was prolonged, and the patient was under anesthesia 45 minutes longer.No patient harm, or injury due to this issue occurred.Manufacturer reference # (b)(4).

Event Description

Manufacturer reference # (b)(4).

Manufacturer Narrative

The affected table was inspected by a getinge-maquet service technician.He stated that the described malfunction could not be reproduced.The customer stated that the table worked fine after the reported incident.It was registered that there was a pressure issue with the pedal switches and related sensors, but when the table was tested by the service technicians it was working fine.We assume that a use error has most likely caused or contributed to the issue.In the instructions for use (ifu) it is described how the castors of the table can be retracted to lock the table.If the table is locked, this is registered by a pressure switch.In the ifu it is described that a pedal needs to be pushed upwards for approximately 5 seconds to retract the castors and lock the table.During the reproduction with a comparable column, it was found that in case the pedal is pushed up not long enough, the castors are retracted, but some pressure is left in the hydraulic system for extracting the castors.Since the hydraulic system is not completely pressure free, a change of the center of gravity (by positioning the patient) can lead to a higher pressure in the hydraulic system.This causes the switching of the pressure switch.If the switch is changed, a signal is sent to the controller board of the table.In case this signal is received and a micro switch indicating a tilt of the table of more than 2° is activated, the tables¿ movements are locked.This is done to prevent the tilting of a table set on the castors, since this situation would pose a risk for the patient.A message on the remote control is shown in this case.The users reported that a message on the remote control was shown, but they did not remember, which one.Getinge-maquet gmbh provides product failure investigation, analysis and resolution for the device described in this report.

• Brand Name: MAGNUS OR-TABLE COLUMN, INDEPEN
• Type of Device: TABLE, OPERATING-ROOM, AC-POWERED
• Manufacturer (Section D): HOLGER ULLRICH; maquet gmbh; kehler strasse 31,; rastatt 76437 ; GM 76437
• MDR Report Key: 10675979
• MDR Text Key: 211237249
• Report Number: 8010652-2020-00021
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/13/2021

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 Operator: Health Professional
• Device Model Number: 118001D0
• Device Catalogue Number: 118001D0
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/07/2020
• Initial Date FDA Received: 10/14/2020
• Supplement Dates Manufacturer Received: 10/12/2021
• Supplement Dates FDA Received: 10/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other