MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SITE-RITE 8 ULTRASOUND SYSTSEM CONSOLE (REMANUFACTURED); SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number 9770501

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Date 12/19/2018

Event Type  malfunction  

Manufacturer Narrative

The manufacturer has received the sample and will be evaluated.Results are expected soon.A lot history review (lhr) review is not possible, as the device is manufactured using a unique serial number and not by lot number.A history review of serial number (b)(4) showed no other similar product complaint(s) from this serial number.

Event Description

It was reported by the service facility that there is interference in the bottom of the image box and the probe buttons function intermittently.

Event Description

It was reported by the service facility that there is interference in the bottom of the image box and the probe buttons function intermittently.

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 device was returned with no alleged deficiency.During evaluation, the service facility found the probe has poor image quality is confirmed.There is interference in the probe image box and the probe buttons intermittently function.The device was tested, serviced, and returned to refurbished inventory.A lot history review (lhr) review is not possible, as the device is manufactured using a unique serial number and not by lot number.A history review of serial number (b)(6) showed no other similar product complaint(s) from this serial number.

• Brand Name: SITE-RITE 8 ULTRASOUND SYSTSEM CONSOLE (REMANUFACTURED)
• Type of Device: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8242927
• MDR Text Key: 133053142
• Report Number: 3006260740-2019-00015
• Device Sequence Number: 1
• Product Code: IYO
• UDI-Device Identifier: 00801741098338
• UDI-Public: (01)00801741098338
• Combination Product (y/n): N
• PMA/PMN Number: K152554
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 08/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9770501
• Device Catalogue Number: 9770600Y
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2018
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/19/2018
• Initial Date FDA Received: 01/12/2019
• Supplement Dates Manufacturer Received: 08/30/2019
• Supplement Dates FDA Received: 08/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1