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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SITE~RITE 5 SCANNER TRANSDUCER, ULTRASONIC, DIAGNOSTIC

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BARD ACCESS SYSTEMS SITE~RITE 5 SCANNER TRANSDUCER, ULTRASONIC, DIAGNOSTIC Back to Search Results
Catalog Number 9760036
Device Problem Computer Software Problem (1112)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records. Based on a review of this information, the following was concluded: the root cause of the reported failure is inconclusive as the reported issue could not be reproduced during evaluation. No issue found, errors inspection and cleaning of error log and system files. A history review of serial number (b)(4) showed one other similar complaint from this serial number. The previous complaint for this serial number (b)(4) evaluation was unconfirmed as failure could not be reproduced (reference: mdr number 3006260740-2020-00962.
 
Event Description
Equipment freezes the display during procedure.
 
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Brand NameSITE~RITE 5 SCANNER
Type of DeviceTRANSDUCER, ULTRASONIC, DIAGNOSTIC
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
Manufacturer (Section G)
DYMAX CORP.
141 zehner school road
zelienople PA 16063
Manufacturer Contact
shelly gilbert
605 n. 5600 w.
salt lake city, UT 84116
8015225640
MDR Report Key9921877
MDR Text Key195093886
Report Number3006260740-2020-01172
Device Sequence Number1
Product Code ITX
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K052517
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 04/03/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number9760036
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/26/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received08/26/2016
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 Reuse

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