MAUDE Adverse Event Report: BRACCO INJENEERING S.A. ARTICULATING ARM OF EMPOWER CTA

Model Number 017417

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/18/2019

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: it is similar to the manufacturer report: 3004753774-2019-00001.The design of the j-arm as well as the manufacturing cannot be considered as the root cause of this failure.The most probable root cause of the failure is the ceiling mount being used after the expected life of the device.

Event Description

On 23-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 11-jun-2019.On (b)(6) 2019, the adjustable mounting arm that is attached to the ceiling with the injector head broke off.With the patient on the table, the j-arm fell from the ceiling.The ct technologist caught the j-arm when it fell, no one, including the patient was harmed.The j-arm was quite damaged with bolts broken inside stretched out holes and three (3) pins sheared off.Preliminary review of data lead to the following conclusion: it is similar to manufacturer report 3004753774-2019-00001.The design of the j-arm as well as the manufacturing cannot be considered as the root cause of this failure.The most probable root cause of the failure is the ceiling mount being used after the expected life of the device.Additional information is required pending the device investigation report findings.

• Brand Name: ARTICULATING ARM OF EMPOWER CTA
• Type of Device: ARTICULATING ARM OF EMPOWER CTA
• Manufacturer (Section D): BRACCO INJENEERING S.A.; 46 avenue sevelin; lausanne, CH-10 04; SZ CH-1004
• Manufacturer (Section G): BRACCO INJENEERING S.A.; 46 avenue sevelin; lausanne, CH-10 04; SZ CH-1004
• Manufacturer Contact: cedric boesch ; 46 avenue sevelin; lausanne, CH-10-04 ; SZ CH-1004
• MDR Report Key: 8711969
• MDR Text Key: 196482503
• Report Number: 3004753774-2019-00002
• Device Sequence Number: 1
• Product Code: IZQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 071378
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 05/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 017417
• Device Catalogue Number: 800840-003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 05/23/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1