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

Model Number 115001C0

Device Problem Defective Device (2588)

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

Event Date 07/16/2018

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 fda (b)(4).

Event Description

It was reported that during a procedure the operating table was not fully functioning.The procedure could not be finished due to the issue.Another procedure had to be performed.No injury has been reported.Manufacturer reference # (b)(4).

Event Description

Manufacturer reference # (b)(4).

Manufacturer Narrative

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, 45 barbour pond drive, wayne, nj 07470, contact person: (b)(4).The customer reported to us that the table system did not work via hand control or via the override control panel.E were informed that the remote control was replaced by the customer and the table worked fine afterwards.The affected remote control was not available for further investigation.A function loss of the remote control might be caused by rough handling such as drop or collusion.We assume that in this case this might be the reason for this kind of malfunction also.Another possible cause could be wear and tear.The or table is equipped with an override control panel which can be used to move the table in case the remote control is defective.In the instruction for use (ifu) the function of the override panel is described.A getinge-maquet service technician inspected the table at the customer site and found the override control panel was working fine.No defect or malfunction of the override panel was detected during the investigation of the system and the hand control which was exchanged by the clinic could not be investigated we assume that the customer did not use the over ride control panel correctly.The use of this override panel is described in the ifu ga115001en25: " in the event of malfunctions or if the hand controls are defective, the operating table system can be operated by means of the override control panel.The override control panel is located on the column.To execute a function, press and hold the release button.Then press the desired function button until the corresponding position is reached.The column can only be moved if the table top is mounted." 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: 7898405
• MDR Text Key: 121565652
• Report Number: 8010652-2018-00021
• 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: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 01/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 115001C0
• Device Catalogue Number: 115001C0
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other