MAUDE Adverse Event Report: HOLGER ULLRICH 118010A0; TABLE, OPERATING-ROOM, AC-POWERED

Model Number 118010A0

Device Problem Positioning Problem (3009)

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

Event Date 07/08/2021

Event Type  malfunction  

Manufacturer Narrative

At time of this report the investigation is still ongoing.When the investigation is complete the report will be updated and a follow up/final report will be submitted.The complete name of the clinic is (b)(6).

Event Description

The following was reported to us.During a surgery the table top could not be operated.That is why the surgery was delayed for approximately 45 minutes.No injury of the patient was reported.Manufacturer reference# (b)(4).

Manufacturer Narrative

The table top (tt) consists of several assemblies, among others of several bars.The position of these bars is registered and adjusted via sensors.These sensors are electromechanical parts which have to be readjusted periodically.In this case these sensors have been mis-adjusted.This resulted in the bars being mis-adjusted, too.In case of such a maladjustment an error is registered at the controller board of the table.In this case an error message was shown, which indicates that this kind of malfunction was present when the issue occurred and has most likely caused it.

Event Description

Manufacturer reference# (b)(4).

• Brand Name: 118010A0
• 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: 12156788
• MDR Text Key: 261231250
• Report Number: 8010652-2021-00022
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 118010A0
• Device Catalogue Number: 118010A0
• Device Lot Number: N/A
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/09/2022
• Date Device Manufactured: 07/15/2015
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 140 KG