MAUDE Adverse Event Report: MAQUET GMBH ALPHAMAXX (460 MM LONGIT. SHIFT), EU; TABLE, OPERATING-ROOM, AC-POWERED

Model Number 113322B5

Device Problems Circuit Failure (1089); Failure to Run on Battery (1466)

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

Event Date 11/08/2023

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.E1i event site telephone: (b)(6).H3 other text : device not returned to manufacturer.

Event Description

On 8th november 2023 getinge became aware of an issue with one of our mobile tables ¿ 113322b5 - alphamaxx (460 mm longit.Shift), eu.As it was stated, the table could not be moved at all during hip surgery on the anesthetized patient even with a use of the override panel due to a failure of charger board and battery.The surgery was continued on the affected device, however, the surgeon had to be seated for the procedure and the staff struggled getting the x-ray machine under the table.No delay in surgery occurred due to the issue.There was no injury reported, however, we decided to report the issue based on the potential for serious injury if the situation, namely inability to move the table during the surgery due to charger board malfunction affecting patient¿s positioning, was to reoccur.

• Brand Name: ALPHAMAXX (460 MM LONGIT. SHIFT), EU
• Type of Device: TABLE, OPERATING-ROOM, 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: 18169373
• MDR Text Key: 328531291
• Report Number: 8010652-2023-00122
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 11/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 113322B5
• Device Catalogue Number: 113322B5
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/08/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/15/2022
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1