MAUDE Adverse Event Report: MAQUET GMBH UNIVERSAL REMOTE CONTROL; TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, AC-POWERED

Model Number 100925A0

Device Problems Communication or Transmission Problem (2896); Positioning Problem (3009)

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

Event Date 10/02/2023

Event Type  malfunction  

Event Description

On 2nd october 2023 getinge became aware of an issue with one of our accessories - 100925a0 universal remote control.As it was stated, the ir code on the universal remote control was changed during a knee prostesis operation on the anesthetized patient.According to the customer's allegation, the column could no longer be controlled due to the issue and the table top could not be adjusted.The issue led to a delay of approximately 3 minutes as the staff tried to organize a replacement remote control.There was no injury reported, however, we decided to report the issue based on the potential for serious injury if the situation, namely the delay in surgery resulting in prolonged anesthesia time, was to reoccur.

Manufacturer Narrative

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

• Brand Name: UNIVERSAL REMOTE CONTROL
• Type of Device: TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, 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: 17919485
• MDR Text Key: 325484295
• Report Number: 8010652-2023-00102
• Device Sequence Number: 1
• Product Code: JEA
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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
• Report Date: 10/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 100925A0
• Device Catalogue Number: 100925A0
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/02/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/13/2022
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1