MAUDE Adverse Event Report: HOLGER ULLRICH MAQUET OR TABLE SYSTEM ALPHAMAQUET; TABLE, OPERATING-ROOM, AC-POWERED

Model Number 115002A0

Device Problem Unintended Movement (3026)

Patient Problems Fall (1848); Head Injury (1879)

Event Date 10/02/2017

Event Type  Injury  

Manufacturer Narrative

The product in question was investigated by (b)(4) - maquet service technicians on 2017-10-03.During the investigation no malfunction was found.Functional testing was performed and no deviation could be detected.All involved products worked as specified.We asked the customer several times regarding the outcome of the patient but just got the reply that this kind of information is confidential.(b)(4) - maquet (b)(4) provides product failure investigation, analysis and resolution for the device described in this report.

Event Description

It was reported by the customer that at the end of a procedure the table tilted unintentionally and the patient fell from the table and injured his head.(b)(4).

• Brand Name: MAQUET OR TABLE SYSTEM ALPHAMAQUET
• 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: 6987703
• MDR Text Key: 90574746
• Report Number: 8010652-2017-00014
• 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
• Report Date: 10/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 115002A0
• Device Catalogue Number: 115002A0
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2002
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other