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U.S. Department of Health and Human Services

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

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BRACCO INJENEERING SA ARTICULATING ARM OF EMPOWER CTA+ Back to Search Results
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.
 
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Brand NameARTICULATING ARM OF EMPOWER CTA+
Type of DeviceARTICULATING ARM OF EMPOWER CTA+
Manufacturer (Section D)
BRACCO INJENEERING SA
lausanne,
SZ
Manufacturer (Section G)
BRACCO INJENEERING S.A.
46 avenue sévélin
lausanne, CH-10 04
SZ CH-1004
Manufacturer Contact
cédric boesch
46 avenue sévélin
lausanne, CH-10-04
SZ   CH-1004
MDR Report Key8641994
MDR Text Key206367151
Report Number3004753774-2019-00001
Device Sequence Number1
Product Code IZQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
071378
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Remedial Action Replace
Type of Report Initial,Followup
Report Date 07/22/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/24/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number017416
Device Catalogue Number017416
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/22/2019
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

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