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

Catalog Number	9770501R
Medical Device Problem Codes	Loss of Power (1475); Battery Problem (2885)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will be evaluated.A supplemental will be submitted with evaluation results.A history review of serial number (b)(4) showed no other similar product complaint(s) from this serial number.
Event or Problem Description
Per tm, unit will not hold a charge.Shuts off at 80% after unplugging.
Event or Problem Description
Per tm, unit will not hold a charge.Shuts off at 80% after unplugging.
Additional 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 unit will not hold a charged was confirmed.The scanner was inspected and fully charged once the scanner reached 71% it abruptly shut off, the cause of the issue is due to internal battery failure.No other functionality issues with the equipment were found during evaluation/servicing.The device was serviced, tested, and returned to the customer.A history review of serial number (b)(4) showed no other similar product complaint(s) from this serial number.

• Brand Name: REFURB, SITE-RITE 8
• Common Device Name: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9131807
• Report Number: 3006260740-2019-02864
• Device Sequence Number: 2528639
• Product Code: IYO
• UDI-Device Identifier: 10801741104135
• UDI-Public: (01)10801741104135
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K152554
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: 9770501R
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 09/04/2019
• Supplement Date Received by Manufacturer: 11/22/2019
• Initial Report FDA Received Date: 09/27/2019
• Supplement Report FDA Received Date: 12/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2243072-10/11/2019-013-C
• Patient Sequence Number: 1