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

Model Number 113322B5

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/08/2018

Event Type  malfunction  

Manufacturer Narrative

Maquet service technician visited the clinic and investigated the product in question.The described malfunction could not be reproduced.The product in question was requested for investigation.At the time of this report the product is on its way to the manufacturer for investigation.Getinge - maquet (b)(4) provides product failure investigation, analysis and resolution for the device described in this report.

Event Description

The customer reported that during a surgery the table went from lock into unlock without anyone using the hand control.It was reported that this was the third time the table did this.No injury has been reported to getinge - maquet.(b)(4).

Manufacturer Narrative

Getinge usa sales, llc (importer) is submitting this report on behalf of the legal manufacturer of the device maquet gmbh, kehler strasse 31, rastatt, germany 76437.Exemption # e2018004.(b)(4), contact person: (b)(6).The table was returned to rastatt for further investigation.During the investigation the issue could be reproduced.The investigation revealed that a combination of unfavorable circumstances caused the described malfunction.These circumstances were worn out locking buffers causing the table to rest on the plates.The plates have a lower friction coefficient than the locking buffers.Switches out of adjustment, in a way that the castors still touch the floor slightly.Software related issue.The software for the locking function might cause the castors to be pressed to the floor.This scenario can occur if the locking key is pressed for more than 2 seconds or pressed , released and pressed again.All three circumstances have to come together to cause the described issue.The worn out locking buffers were replaced and the switches re-adjusted according to specification.Since the launch of the 112222xx product line in 2008, more than (b)(4) products have been manufactured.This is the first complaint in which the described failure has been reported to us.Getinge-maquet gnmh provides product failure investigation, analysis and resolution for the device described in this report.

Event Description

Mfg reference # (b)(4).

• Brand Name: ALPHAMAXX (460 MM LONGIT. SHIFT), EU
• 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: 7272897
• MDR Text Key: 100463812
• Report Number: 8010652-2018-00003
• 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: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 05/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 01/22/2018
• Initial Date FDA Received: 02/15/2018
• Supplement Dates Manufacturer Received: 01/22/2018
• Supplement Dates FDA Received: 05/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1