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

Model Number 9770600

Device Problems No Display/Image (1183); Defective Component (2292)

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

Event Date 07/18/2022

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 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 Description

Per tm - the unit will have half of the image turn black out of nowhere in the middle of procedures.

Manufacturer Narrative

H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.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 the information, the following was concluded: the device was returned to the service facility for evaluation.During evaluation, the reported issue of screen is only displaying on one side was confirmed.Ran the scanner power on for 24 hours and the image did turn black one time.The root cause of the failure was identified as a motherboard failure.

Event Description

Per tm - the unit will have half of the image turn black out of nowhere in the middle of procedures.

• Brand Name: SITE~RITE 8 ULTRASOUND SYSTEM CONSOLE WITH CONNECTOR
• 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: 15123232
• MDR Text Key: 302582181
• Report Number: 3006260740-2022-02940
• Device Sequence Number: 1
• Product Code: IYO
• UDI-Device Identifier: 00801741138263
• UDI-Public: (01)00801741138263
• 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: Other,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9770600
• Device Catalogue Number: 9770600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other