MAUDE Adverse Event Report: BRACCO INJENEERING SA ARTICULATING ARM OF EMPOWER CTA+

Model Number 017416

Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/06/2019

Event Type  malfunction  

Manufacturer Narrative

The adjustable mounting arm that is attached to the ceiling with the injector head broke off.Waiting for the device to be returned to manufacturer for investigation.Preliminary review of pictures of broken arm and data provided, led to the following conclusion: the investigation shows that the general aspect of the arm tends to indicate that the j-arm has been used before, that the subassembly j-arm/tube has been damaged by hospital before the full breakage but no part has been replaced.The design of the j-arm as well as the manufacturing cannot be considered as the root cause of this failure.The probable root cause of the failure is the ceiling mount being used after the expected life of the device.The labels provide information that the arm was manufactured in 2006.The use of life of the arm is 5 years.(b)(4).

Event Description

On (b)(6) 2019, a healthcare professional reported to bracco injeneering a device malfunction with the use of the articulating arm of empowercta+.The report was forwarded to bracco drug safety on (b)(6) 2019.On (b)(6) 2019, the adjustable mounting arm that is attached to the ceiling with the injector head broke off.The ct technician loaded the power injector and then while she turned it to bring the injector towards the scanner, the mounting arm just broke off.The injector landed in the tech's arms and she had to get someone to bring in a chair to put the power injector.There was a patient on the ct table at the time the arm fell.There was no injury to the patient (no patient identifiers provided).The manufacturer (b)(4) is waiting for the device to be returned for quality investigation.Preliminary review of pictures of broken arm and data provided, lead to the following conclusion: the investigation shows that the general aspect of the arm tends to indicate that the j-arm has been used before, that the subassembly j-arm/tube has been damaged by hospital before the full breakage but no part has been replaced.The design of the j-arm as well as the manufacturing cannot be considered as the root cause of this failure.The probable root cause of the failure is the ceiling mount being used after the expected life of the device.The labels provide information that the arm was manufactured in 2006.The use of life of the arm is 5 years.Additional information is required pending the device investigation report findings.

Event Description

On 07-may-2019, a healthcare professional reported to bracco injeneering a device malfunction with the use of the articulating arm of empowercta+.The report was forwarded to bracco drug safety on 21-may-2019.On (b)(6) 2019, the adjustable mounting arm that is attached to the ceiling with the injector head broke off.The ct technician loaded the power injector and then while she turned it to bring the injector towards the scanner, the mounting arm just broke off.The injector landed in the tech's arms and she had to get someone to bring in a chair to put the power injector.There was a patient on the ct table at the time the arm fell.There was no injury to the patient (no patient identifiers provided).The manufacturer (binj) is waiting for the device to be returned for quality investigation.Preliminary review of pictures of broken arm and data provided, lead to the following conclusion: the investigation shows that the general aspect of the arm tends to indicate that the j-arm has been used before, that the subassembly j-arm / tube has been damaged by hospital before the full breakage but no part has been replaced.The design of the j-arm as well as the manufacturing cannot be considered as the root cause of this failure.The probable root cause of the failure is the ceiling mount being used after the expected life of the device.The labels provide information that the arm was manufactured in 2006.The use of life of the arm is 5 years.On 22-jul-2019, the results of quality investigation became available.The investigation show that the j-bow parts broke out.It is the cause of the power injector felt down.The j-bow is actually composed of a shaft and bended tube assembled together with 3 screws.These screws, due to the fatigue shear constraints broke.The tube which holds the injector fell down whereas the shaft stayed solidarized with the articulating arm.The wear and tear of these j-bow assembly is the cause of this failure.Most recent follow-up information incorporated above includes: on 22-jul-2019: investigation results provided and added to the case.This case is medically closed.

Manufacturer Narrative

The adjustable mounting arm that is attached to the ceiling with the injector head broke off.Waiting for the device to be returned to manufacture for investigation.Preliminary review of pictures of broken arm and data provided, led to the following conclusion: the investigation shows that the general aspect of the arm tends to indicate that the j-arm has been used before, that the subassembly j-arm / tube has been damaged by hospital before the full breakage but no part has been replaced.The design of the j-arm as well as the manufacturing cannot be considered as the root cause of this failure.The probable root cause of the failure is the ceiling mount being used after the expected life of the device.The labels provide information that the arm was manufactured in 2006.The use of life of the arm is 5 years bracco diagnostics inc.(importer) is submitting the report on behalf of bracco injeneering s.A.(manufacturer) under exemption number e2018011.

• Brand Name: ARTICULATING ARM OF EMPOWER CTA+
• Type of Device: ARTICULATING ARM OF EMPOWER CTA+
• Manufacturer (Section D): BRACCO INJENEERING SA; lausanne, ; SZ
• MDR Report Key: 8641994
• MDR Text Key: 206367151
• Report Number: 3004753774-2019-00001
• Device Sequence Number: 1
• Product Code: IZQ
• Combination Product (y/n): N
• PMA/PMN Number: 071378
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 07/22/2019

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: No Information
• Device Model Number: 017416
• Device Catalogue Number: 017416
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/07/2019
• Initial Date FDA Received: 05/24/2019
• Supplement Dates Manufacturer Received: 07/22/2019
• Supplement Dates FDA Received: 08/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1