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 Apparent Adverse Event (3189); Application Program Freezes, Becomes Nonfunctional (4031)

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

Event Date 04/26/2021

Event Type  malfunction  

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 two other similar product complaint(s) from this serial number.The complaints for this serial number have been reported from the same facility.

Event Description

Per rn - this afternoon i had the loaner u/s to freeze 3 times.I could not do anything on the touch screen or the buttons on the probe.The 1st time it lasted about 3 minutes.The screen blinked or flashed and then it started working.The battery was charged at 96 - 98 % each time.Since that time i have used it about 3 hours and no other issues.This file represents the first of three reported events.

Event Description

Per rn - this afternoon i had the loaner u/s to freeze 3 times.I could not do anything on the touch screen or the buttons on the probe.The third time lasted about 1-2 minutes.The screen blinked or flashed and then it started working.The battery was charged at 96 - 98 % each time.Since that time i have used it about 3 hours and no other issues.

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 this information, the following was concluded: the device was returned to the service facility for evaluation.During evaluation, the reported issue of program freezes is unconfirmed.The unit did not freeze in assessment.The root cause of the reported failure was identified as use-related probe failure.The device was serviced, tested, and returned refurbished inventory.A history review of serial number (b)(6) showed two other similar product complaint(s) from this serial number.The complaints for this serial number have been reported from the same facility.H3 other text : evaluation findings are in section h.11.

• 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
• MDR Report Key: 11863398
• MDR Text Key: 252164384
• Report Number: 3006260740-2021-01921
• Device Sequence Number: 1
• Product Code: IYO
• UDI-Device Identifier: 00801741138263
• UDI-Public: (01)00801741138263
• Combination Product (y/n): N
• PMA/PMN Number: K152554
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 06/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2021
• 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: 05/19/2021
• Date Manufacturer Received: 06/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other