MAUDE Adverse Event Report: HOLGER ULLRICH MAGNUS CARB.-FIBRE TABLE TOP, LONG BOLUS; TABLE, RADIOLOGIC

Model Number 118016A2

Device Problems Use of Device Problem (1670); Insufficient Information (3190)

Patient Problems Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/05/2021

Event Type  Death  

Manufacturer Narrative

A getinge-maquet field service engineer has visited the clinic and investigated the products.No damage or malfunction was found on the table top or the tables column.We are in contact with the clinic to evaluate and investigate all aspects that might have contributed to the outcome of the cpr.The used column is 118001b1, serial#: (b)(4), hybrid or table column, surface-mounted.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.

Event Description

The following was reported to us.A cardiopulmonary resuscitation (cpr) was performed on the operation room table top 1180.16a2 which was mounted on the operating room table column 118001b1.The cpr was not successful and the patient died.Manufacturer reference#: (b)(4).

Manufacturer Narrative

A getinge-maquet field service engineer has visited the clinic and investigated the products.No damage or malfunction was found on the table top or the table column.The used or table top 118016a2 can be moved relative to the or table column in the longitudinal direction.According to this longitudinal shift, there might be some play.This play makes the cardiopulmonary resuscitation (cpr) more difficult.In the instructions for use (ifu) the user is advised to adjust the longitudinal shift of the table top, if necessary.A way to minimize the play is to center the 118016a2 table top over the column.According to the clinic, the table top was not centered above the column, but 3/4 the way towards the head end.The clinic was familiar with the fact that the table top can be centered above the column to minimize the play and relative movement of the table top.It is possible to perform a cpr in any position without the risk of material failure.No damage or malfunction was found on the table top or the tables column.Based on the investigation we conclude that no malfunction or damage of the table has contributed to the outcome of the cpr.Concerning the code 4581 for "health effects - clinical signs and symptoms or conditions" we would like to add the following: a cardiopulmonary resuscitation (cpr) was not successful and the patient died.We do not know why the cpr was required in the first place.Getinge-maquet gmbh provides product failure investigation, analysis and resolution for the device described in this report.

Event Description

Manufacturer reference# (b)(4).

• Brand Name: MAGNUS CARB.-FIBRE TABLE TOP, LONG BOLUS
• Type of Device: TABLE, RADIOLOGIC
• Manufacturer (Section D): HOLGER ULLRICH; maquet gmbh; kehler strasse 31,; rastatt 76437 ; GM 76437
• MDR Report Key: 11504609
• MDR Text Key: 240337247
• Report Number: 3013876692-2021-00021
• Device Sequence Number: 1
• Product Code: KXJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 07/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 118016A2
• Device Catalogue Number: 118016A2
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/06/2021
• Distributor Facility Aware Date: 06/25/2021
• Event Location: Hospital
• Date Report to Manufacturer: 07/06/2021
• Date Manufacturer Received: 06/25/2021
• Patient Sequence Number: 1
• Treatment: USED COLUMN: 118001B1, SERIAL (B)(6); USED COLUMN: 118001B1, SERIAL (B)(4)
• Patient Outcome(s): Death