MAUDE Adverse Event Report: MAQUET GMBH 1150 OR-TABLE COLUMN, MOBIL; TABLE, OPERATING-ROOM, AC-POWERED

Model Number 115002C0

Device Problems Mechanical Jam (2983); Positioning Problem (3009)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.E1b event site name: (b)(6).H3 other text : device not returned to manufacturer.

Event Description

On (b)(6) 2023 getinge became aware of an issue with one of our columns - 115002c0 - 1150 or-table column, mobil.As it was stated, during the procedure, when the operator was lowering the headrest, the "cracking/breaking" sounds appeared.The patient was transported to another room and the procedure was completed.According to information provided following service visit on site, the linear drive unit was found to be defective.There was no injury reported, however, we decided to report the issue based on the potential for serious injury if the situation, namely drive unit malfunction during procedure which could result in unintended motion or unavailability of movements, was to reoccur.

Manufacturer Narrative

Getinge became aware of an issue with one of our columns - 115002c0 - 1150 or-table column, mobil.As it was stated, during the procedure, when the operator was lowering the headrest, the "cracking/breaking" sounds appeared.The patient was transported to another room and the procedure was completed.According to information provided following the service visit on site, the linear drive unit was found to be defective.There was no injury reported, however, we decided to report the issue based on the potential for serious injury if the situation, namely drive unit malfunction during the procedure which could result in unintended motion or unavailability of movements, was to reoccur.With the investigation performed it was concluded that upon the event occurrence, the device was being used for the patient¿s treatment and was also directly involved with the reported incident.As the malfunction of the drive unit and several different parts were found, it was concluded that the getinge device was not up to the specification.A review of the received customer product complaints revealed that there were no injuries to a user nor to a patient or operator when this particular malfunction occurred.The issue investigated herein is a single and isolated case.The affected getinge device has been evaluated by the technician.The evaluation performed by the technician revealed that the following parts were defective: linear drive unit (part number 31140122), spacing washer 16,5/ 25 0,8 (part number 84018724), bolt for traction fork (part number 50097274), knee connector (part number 66047494), slot bolt (part number 50098814), circlip din471- 20x1,2 -fed-st (part number 15020219), adjusting washer din988-20x28x0,1 (part number 13350149), distance bush (part number 50097104) and bolt for motor support (part number 50104964).The affected table column was manufactured in october 2012.The review of the customer product complaint database revealed that in the past, there were no customer product complaints related to their malfunction.Therefore, it can be concluded that these parts were never replaced and were in use for 11 years.During the evaluation of the affected device, the technician tried to remove the top from the column.During this attempt, the second linear drive broke.The customer received a quote for the damaged parts, however, the quotation was not accepted.The customer will order a new table column to replace the affected device.In summary and as a result of the root cause evaluation, it can be concluded that the reported issue, namely the drive unit malfunction during the procedure which could result in unintended motion or unavailability of movements, was most likely related to the age of the device as the affected parts were most probably in use for 11 years.We currently do not have any information that would warrant further action towards the device manufacturing or devices on the market, however as per our complaint handling processes will continue to monitor the customer experiences with the device for any future information.The correction of h4 device manufacture date field deems required.This is based on the internal evaluation.Previous h4 device manufacture date: 07/01/2012.Corrected h4 device manufacture date: 10/16/2012.

Event Description

Manufacturer's reference number (b)(4).

• Brand Name: 1150 OR-TABLE COLUMN, MOBIL
• Type of Device: TABLE, OPERATING-ROOM, AC-POWERED
• Manufacturer (Section D): MAQUET GMBH; kehler strasse 31; rastatt ; GM
• Manufacturer (Section G): MAQUET GMBH; kehler strasse 31; rastatt ; GM
• Manufacturer Contact: holger ullrich ; kehler strasse 31; rastatt ; GM
• MDR Report Key: 18266693
• MDR Text Key: 329728046
• Report Number: 8010652-2023-00132
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Reporter Country Code: PL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 115002C0
• Device Catalogue Number: 115002C0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/16/2012
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1