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

Model Number 112000A0

Device Problem Unintended Movement (3026)

Patient Problem Hematoma (1884)

Event Date 07/11/2017

Event Type  Injury  

Manufacturer Narrative

A (b)(4) ¿ maquet service technician was on site and has investigated the product in question.No malfunction was detected during the investigation.The failure described by the customer could not be reproduced.When checking the complaints database no further cases could be found with the described failure and the complained product.The product in question has been in clinical use since 1991.The customer has confirmed that the failure described has never occurred in the past.A foot switch and a hand control are available to the customer for the operation of the product.Based on the results of the examination we assume that the failure described by the customer was triggered by an unnoticed / unintentional actuation of the foot switch or the hand control.Maquet (b)(4) provides product failure investigation, analysis and resolution for the device described in this report.(b)(4).

Event Description

The customer reported that during an outpatient surgery in local anesthesia at the end of the surgery the operating table has moved upwards without any apparent reason.The patient was pinched between the operating table and the c-arm.The patient suffered a hematoma on the right leg.(b)(4).

• Brand Name: MAQUET, OR TABLE SYSTEM
• 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: kehler strasse 31; rastatt 76437
• MDR Report Key: 6784435
• MDR Text Key: 82370918
• Report Number: 8010652-2017-00008
• 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: 08/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 112000A0
• Device Catalogue Number: 112000A0
• Was Device Available for Evaluation?: Yes
• Device Age: YR
• Date Manufacturer Received: 07/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/15/1991
• 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
• Patient Age: 70 YR