MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SITE-RITE PREVUE; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Catalog Number 9770090

Device Problems Failure to Power Up (1476); Unexpected Shutdown (4019)

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

Event Type  malfunction  

Manufacturer Narrative

The manufacturer has received the sample and will be evaluated.Supplemental will be submitted with evaluation results.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

Per picc nurse, the battery light wont turn on, the scanner shuts off when not plugged in and the scanner doesn't boot up.

Event Description

Per picc nurse, the battery light wont turn on, the scanner shuts off when not plugged in and the scanner doesn't boot up.

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 to the service facility for evaluation.During evaluation, the reported issue of the battery light will not turn on was confirmed.The root cause of the reported issue was due to the lithium ion battery.The device was serviced, tested and returned to customer.A history review of serial number (b)(6) showed no other similar product complaint(s) from this serial number.

• Brand Name: SITE-RITE PREVUE
• 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: 8677167
• MDR Text Key: 147307493
• Report Number: 3006260740-2019-01581
• Device Sequence Number: 1
• Product Code: IYO
• UDI-Device Identifier: 00801741125058
• UDI-Public: (01)00801741125058
• Combination Product (y/n): N
• PMA/PMN Number: K120882
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 07/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9770090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2019
• Event Location: Hospital
• Date Manufacturer Received: 06/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1