MAUDE Adverse Event Report: HOLGER ULLRICH TABLE, OPERATING ROOM, AC POWERED; TABLE, OPERATING-ROOM, AC-POWERED

Model Number 118001D0

Device Problems Mechanical Problem (1384); Use of Device Problem (1670)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 11/17/2018

Event Type  malfunction  

Manufacturer Narrative

At the time of this report the investigation was still ongoing.As soon as the investigation is finished the report will be updated and a follow-up/final report will be provided to the fda.(b)(4).

Event Description

It was reported by the customer that during an ongoing surgery, the operating table could not be operated anymore.The surgery was finished in an unsuitable position.The patient needed to the transferred to his bed for wake up and needed an extra dose of medication.The wake up was reported to be slightly delayed.No injury has been reported.(b)(4).

Event Description

Manufacturer reference number: 2018-61551.

Manufacturer Narrative

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, 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.We assume that a use error has caused the described malfunction.The customer has not actuated the pedal long enough and this has caused some pressure within the mentioned system.The customer reported that table was set into a trendelenburg position and tilted.We assume that this has caused the center of gravity to shift and the pressure within the system to incline.This has caused the pressure switch to be activated.Since the pressure switch was activated and the microswitch for tilt was activated, the tables functions were blocked.Maquet gmbh provides product failure investigation, analysis and resolution for the device described in this report.

• Brand Name: TABLE, OPERATING ROOM, AC POWERED
• 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: 8180799
• MDR Text Key: 131005962
• Report Number: 8010652-2018-00029
• 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: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 07/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• 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
• Date Manufacturer Received: 06/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other