MAUDE Adverse Event Report: HOLGER ULLRICH MAGNUS TABLE COLUMN FOR BUILT-IN PLATE; TABLE, OPERATING-ROOM, AC-POWERED

Model Number 118001A0

Device Problems Circuit Failure (1089); Insufficient Information (3190)

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

Event Date 06/18/2021

Event Type  malfunction  

Manufacturer Narrative

At the time of this report the investigation is still ongoing.When the investigation is complete the report will be updated and a follow up medwatch will be submitted.

Event Description

The following was reported to us.A patient was prepared for a surgery and the table column 118001a0 was in use.The patient was intubated, but the surgery was not yet started, when a malfunction of the table occurred.The table could not be moved.That is why the intubated patient was transferred to another table on which the surgery could be performed.A delay of approximately 50 minutes occurred due to this issue.The patient was not injured.We were informed about the malfunction on the (b)(6) 2021.On the (b)(6) 2021 we were informed about a mayor delay of the surgery.Manufacturer reference #: (b)(4).

Manufacturer Narrative

A getinge-maquet field service engineer has investigated the affected table and found that the tables control board was defective.Unfortunately the affected board was scraped and is no longer available for further investigation.A review of the complaints database results in no previous complaints for the affected or cable column (product number 118001a0, serial number (b)(6)).Therefore we assume the affected control board is in use for more than 10 years.We assume wearing to be the most probable root cause for this failure.The board is mounted inside the or table column and protected by the or tables' covers from environmental influences.That is why we assume that it was most likely not damaged by the user.Another possible root cause would be an electro static discharge (esd) event.Whenever the tables internals, like the board are accessible (e.G.During repair or maintenance work) there is the risk that the esd precautions are not followed and the electric parts are damaged afterwards.Maquet service technicians are taught how esd precautions can be followed during their daily work, e.G.During service trainings in rastatt.That¿s why we assume it is highly unlikely that the parts are subject to esd damage during maintenance work performed by getinge - maquet service technicians.In the instructions for use (ifu) the user is told not to repair a defective product.However, we cannot exclude that repair or maintenance work was performed on the table by the clinics biomed or an unauthorized company.H3 other text: device not returned to manufacturer.

Event Description

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

• Brand Name: MAGNUS TABLE COLUMN FOR BUILT-IN PLATE
• Type of Device: TABLE, OPERATING-ROOM, AC-POWERED
• Manufacturer (Section D): HOLGER ULLRICH; maquet gmbh; kehler strasse 31,; rastatt 76437 ; GM 76437
• Manufacturer (Section G): HOLGER ULLRICH; maquet gmbh; kehler strasse 31,; rastatt 76437 ; GM 76437
• Manufacturer Contact: maquet gmbh; kehler strasse 31,; rastatt 76437
• MDR Report Key: 12156789
• MDR Text Key: 261285426
• Report Number: 8010652-2021-00023
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 118001A0
• Device Catalogue Number: 118001A0
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/10/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/15/2009
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other