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

Model Number 115030BO

Device Problem Device Slipped (1584)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/13/2018

Event Type  malfunction  

Manufacturer Narrative

At the time of this report the investigation was still on-going.When the investigation is complete the report will be updated and submitted.Getinge-maquet (b)(4) service technician visited the clinic and investigated the device.The described issue could be confirmed.All dished plates and rubber buffers have been replaced , the toothed disks have been ordered and will be replaced as soon as they arrive.The device was placed out of service until all repair measures are completed.(b)(4).

Event Description

It was reported that during a procedure the head rest of the table top gave way although the head rest was locked properly.The patient was transferred to another table and the procedure was finished with approx.40 minutes delay.No injury reported.(b)(4).

Manufacturer Narrative

The affected product was manufactured in 2006.The following malfunction was reported: the attached shoulder plate gave way during use when someone bumped against it.The shoulder plate is locked at the table interface via two toothed discs which are pre-loaded via rubber buffers.A getinge-maquet gmbh service technician visited the clinic and investigated the product in question.All toothed discs and rubber buffers have been replaced.The described issue could be caused by work out tooth discs and/or rubber buffers, or the connection was not properly secured by the customer, or the connection was loosened unnoticed during the procedure, or the connection gave way due to overload, or an unfortunate combination of the described situations.In the instructions for use (ifu) it is stated that getinge-maquet products may used only when fully functional.Further it is stated that the devices have to be checked/inspected for functional and mechanical integrity before utilization.In this case the exact root cause could not be identified.We assume that a combination of slightly worn parts in combination with overload and/or a not properly secured connection caused the described issue.Getinge-maquet gmbh provides product failure investigation, analysis, and resolution for the device described in this report.Getinge usa sales, llc (importer) is submitting this report on behalf of of the legal manufacturer of the device maquet gmbh, kehler strasse 31, rastatt, germany 76437.Exemption # e2018004 getinge usa sales, llc (b)(6).

Event Description

Man.Ref # (b)(4).

• Brand Name: MODULAR UNIVERSAL TABLE TOP
• 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: 7832602
• MDR Text Key: 118876792
• Report Number: 8010652-2018-00016
• 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: 12/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 115030BO
• Device Catalogue Number: 115030BO
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention