MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SITE~RITE 8 ULTRASOUND SYSTEM; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number N/A

Device Problem Failure to Read Input Signal (1581)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.The device has not been returned to the manufacturer, at this time, for evaluation.A history review of serial number dyaxad076 showed no other similar complaint(s) from this serial number.Device has not yet been returned for evaluation.

Event Description

It was reported the monitor kept freezing.No other information was provided.

Manufacturer Narrative

The following were reviewed as part of this investigation: patient severity, trend analysis, 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 complaint of monitor is freezing was inconclusive because the reported issue could not be reproduced during evaluation of the sample at the service facility.The manufacture site reported that the scanner passed functional testing requirements.Manufacturing records were reviewed and no potential contributing factors were found during manufacture and quality inspection of the device.A history review of serial number (b)(4) showed no other similar complaint(s) from this serial number.

Event Description

It was reported the monitor kept freezing.No other information was provided.

• Brand Name: SITE~RITE 8 ULTRASOUND SYSTEM
• Type of Device: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): DYMAX CORP. -2523003; 110 marshall drive; warrendale PA 15086
• Manufacturer Contact: kelsey erickson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225937
• MDR Report Key: 7268626
• MDR Text Key: 100149489
• Report Number: 3006260740-2018-00197
• Device Sequence Number: 1
• Product Code: IYO
• UDI-Device Identifier: 00801741098208
• UDI-Public: (01)00801741098208
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K152554
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 9770550
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 07/17/2018
• 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
• Patient Sequence Number: 1