MAUDE Adverse Event Report: MAQUET GMBH MAGNUS CARB.-FIBRE TABLE TOP, LONG; TABLE, RADIOLOGIC

Model Number 118016A2 - MAGNUS CARB.-FIBRE TABLE TOP, LONG BOLUS

Device Problem Break (1069)

Patient Problem Laceration(s) (1946)

Event Date 01/06/2020

Event Type  Injury  

Manufacturer Narrative

It was reported that the carbon table top was damaged.A getinge ¿ maquet service technician was on site and inspected the product in question.It was detected that edges of the carbon table top were chipped off.This kind of damage is caused due to collision of the table top and obstacles under the table top or when colliding with obstacles against the table top.In the instructions for use (ifu) the user is warned concerning the risks related to collisions and advised as follows: "during the adjustment procedures, always pay attention to the or table and accessories and avoid collisions.Ensure that tubes, cables and drapes are not trapped." besides the user is told in the ifu not to use a defective product.We assume that this issue occurred due to a use error.The product was damaged due to a use error and afterwards the product was used despite the mentioned damages.No serious injury or required medical intervention was reported.Since the extent of the reported cut is unknown, we err on the side of caution and report this as serious injury.Getinge-maquet gmbh provides product failure investigation, analysis and resolution for the device described in this report.The complete event site name is queen elizabeth university hospital glasgow and the postal code is g51 4tf.

Event Description

It was reported that the table top was damaged due to a collision.A user has cut his or her hand on the damaged surface during cleaning.Manufacturer reference# (b)(4).

• Brand Name: MAGNUS CARB.-FIBRE TABLE TOP, LONG
• Type of Device: TABLE, RADIOLOGIC
• Manufacturer (Section D): MAQUET GMBH; kehler strasse 31; rastatt
• 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: 9574991
• MDR Text Key: 174942767
• Report Number: 8010652-2020-00002
• Device Sequence Number: 1
• Product Code: KXJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 118016A2 - MAGNUS CARB.-FIBRE TABLE TOP, LONG BOLUS
• Device Catalogue Number: 118016A2
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/06/2020
• Initial Date FDA Received: 01/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/15/2014
• 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