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U.S. Department of Health and Human Services

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

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BRACCO INJENEERING S.A. ARTICULATING ARM OF EMPOWER CTA Back to Search Results
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.
 
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Brand NameARTICULATING ARM OF EMPOWER CTA
Type of DeviceARTICULATING 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 Key8711969
MDR Text Key196482503
Report Number3004753774-2019-00002
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 Other Health Care Professional
Remedial Action Replace
Type of Report Initial
Report Date 05/23/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/19/2019
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number017417
Device Catalogue Number800840-003
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received05/23/2019
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 Unkown

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