MAUDE Adverse Event Report: HOLGER ULLRICH ALPHAMAXX MOTOR DRIVE UNIT, EU SIDE RAIL; TABLE, OPERATING-ROOM, AC-POWERED

Model Number 113322B5

Device Problems Electrical /Electronic Property Problem (1198); Insufficient Information (3190)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 12/11/2020

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 medwatch will be submitted.The complete event site name is: (b)(6).

Event Description

The following was reported.During a surgery, there was a fire on the operating tables power supply.No harm of a patient or user was reported.Serious injury in case of recurrence cannot be excluded.Manufacturer reference #: (b)(4).

Event Description

After further communication with the clinic, we became aware that this incident did not occur during a surgery as stated in our initial report.While preparing the room and table for the surgery, a fire occurred on the tables power supply.No harm of a patient or user was reported.Serious injury in case of recurrence cannot be excluded.Manufacturer reference # (b)(4).

Manufacturer Narrative

A getinge-maquet service technician has investigated the affected table.He has found that the tables power cable outer sheath was damaged.This might be because it was trapped under the operating table.The tables fuses were intact and not triggered.The tables transformer was checked and found to be working correctly.The tables error logs were checked and no problems were found.The hospitals staff used a fire extinguisher on the table.We assume that this issue was caused due to the damaged power cable or a contact of live parts with some liquid.Since the mains power supply of the table was soiled by the fire extinguisher fluid, no traces of liquid could be found on the table.Since the mains cables sheath was found to be damaged, we assume that this has most likely caused the issue.We assume that this incident occurred due to a use error.In the instructions for use (ifu) the user is warned not to use defective products and advised to check them: "warning! risk of injury! faulty or defective products may result in injuries.Before use, check the proper working order and fully functional state of the product.Stop using faulty or defective products and inform the getinge representative." further the user is warned that objects can be trapped under the table if it is lowered: "warning! risk of injury! when setting down the or table, there is a risk of crushing and shearing to the feet or objects.Before putting down the or table, make sure there are no objects located under the or table base.When lowering the or table, keep sufficient distance to the or table base." getinge-maquet gmbh provides product failure investigation, analysis and resolution for the device described in this report.

• Brand Name: ALPHAMAXX MOTOR DRIVE UNIT, EU SIDE RAIL
• 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: 11025639
• MDR Text Key: 222060286
• Report Number: 8010652-2020-00028
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• 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
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other