MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 SITE-RITE 8 ULTRASOUND SYSTSEM CONSOLE (REMANUFACTURED); SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number 9770600Y

Device Problem Unexpected Shutdown (4019)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/06/2022

Event Type  malfunction  

Manufacturer Narrative

The date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.The device has not been received by the manufacturer for evaluation.A history review of serial number (b)(4) showed no other similar product complaint(s) from this serial number.

Event Description

Unit is still randomly shutting down when on battery.

• Brand Name: SITE-RITE 8 ULTRASOUND SYSTSEM CONSOLE (REMANUFACTURED)
• Type of Device: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): DYMAX CORP. -2523003; 110 marshall drive; warrendale PA 15086
• Manufacturer Contact: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 15013808
• MDR Text Key: 299070604
• Report Number: 3006260740-2022-02708
• Device Sequence Number: 1
• Product Code: IYO
• UDI-Device Identifier: 00801741138287
• UDI-Public: (01)00801741138287
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182281
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 07/07/2022

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: 9770600Y
• Device Catalogue Number: 9770600Y
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/06/2022
• Initial Date FDA Received: 07/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 2243072-10/11/2019-013-C
• Patient Sequence Number: 1
• Patient Outcome(s): Other