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

Model Number 118001DO

Device Problems Electrical /Electronic Property Problem (1198); 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 06/11/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation is ongoing.Maquet gmbh provides product investigation, analysis and resolution for the device described in this report.

Event Description

It was reported that the table system stopped working during surgery.The procedure was finished successfully on the table, but was prolonged for approximately 40 minutes due to the issue.(b)(4).No injuries reported to getinge-maquet.

Manufacturer Narrative

The customer stated that the described malfunction occurred, when the table was tilted.A getinge-maquet service technician visited the customer and investigated the product in question.The service technician has found that one led was not working.Further he found a loose pump which is used to put the table on its wheels.The service technician changed the led and the pedal interlock board, which is connected to it.A malfunction at the interlock board can contribute to the issue described above.A defect at this board might simulate an activated switch, even in case the switch is not activated.An activated switch can cause the table to lock for the safety reasons.This is described in further detail below.One possible root cause for a defect at the affected board could be an electro static discharge (esd) event.The board might be pre damaged during production (at the supplier), handling like packing, storage or unpacking (supplier or maquet), during mounting (at maquet) or during repair or service work at the hospital.We have evaluated our complaint database concerning the malfunction of the interlock board.No complaints were reported in which a malfunction of this board has occurred.The table can be set on its wheels by operating a pump.The service technician found that this pump was loose and it took several pump steps to rise the column of the floor.Since the described malfunction has not occurred when trying to set the table on the wheels, we assume that the loose pump has not contributed to the described issue.In the ifu the user is advised to only use a product which is fully functional and in good working condition.Further the user is advised to check the product prior to use to ensure it is working properly.Besides by a defect at the mentioned interlock board, the issue can be caused by a use error.If the user has not actuated the pedal (for locking the table) long enough, this can cause some pressure within the mentioned system.The customer reported that the table stopped working once tilt was operated.This might lead to the following situation: the pressure switch was actuated and the microswitch for tilting was operated, too.Since the pressure switch was activated and the microswitch for tilt was activated, the tables¿ functions were blocked.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.We cannot determine, whether the described malfunction was caused by a use error or due to a component failure or both.We assume a use error to be the most probable root cause for this issue, since no other complaints related to the defect at the interlock board were received.Maquet gmbh provides product investigation, analysis and resolution for the device described in this report.

Event Description

Mfg.Reference#: (b)(4).

• Brand Name: MAGNUS-OR-COLUMN
• 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: 7677515
• MDR Text Key: 114022306
• Report Number: 8010652-2018-00011
• 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: 09/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 118001DO
• Device Catalogue Number: 118001DO
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1