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

Model Number 9770086

Device Problems Loss of Power (1475); Charging Problem (2892)

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

Event Type  malfunction  

Manufacturer Narrative

The manufacturer has received the sample and is pending evaluation.Results are expected soon.A history review of serial number (b)(4) showed no other similar complaint(s) from this serial number.

Event Description

Per clinical engineer: the scanner fails to hold a charge, indicator shows it is charging but when the unit is unplugged it shuts off.

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 will not hold a charge is confirmed.The root cause is due to the internal lithium-ion battery.No other functionality issues with the equipment were found during evaluation/servicing.The device was serviced, tested and returned to the customer.The manufacturer has received the sample and is pending evaluation.Results are expected soon.A history review of serial number dybxq500 showed no other similar complaint(s) from this serial number.

Event Description

Per clinical engineer: the scanner fails to hold a charge, indicator shows it is charging but when the unit is unplugged it shuts off.

• Brand Name: SITE~RITE PREVUE+ 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
• MDR Report Key: 8468059
• MDR Text Key: 140517784
• Report Number: 3006260740-2019-00747
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 00801741095450
• UDI-Public: (01)00801741095450
• Combination Product (y/n): N
• PMA/PMN Number: K150529
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 06/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9770086
• Device Catalogue Number: 9770086R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2019
• Event Location: Hospital
• Date Manufacturer Received: 05/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1