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

Model Number 9770501R

Device Problems No Apparent Adverse Event (3189); Application Program Freezes, Becomes Nonfunctional (4031)

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

Event Date 05/26/2021

Event Type  malfunction  

Manufacturer Narrative

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

Per tm - unit is freezing on the main screen.

Event Description

Per tm - unit is freezing on the main screen.

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.During the evaluation, the reported issue of the screen is freezing was unconfirmed.The sr8 was tested, ran overnight, and functioned to manufacturer specifications with no freezing noted.The root cause of the reported failure is inconclusive as the reported issue could not be reproduced during evaluation.A history review of serial number (b)(6) showed no other similar product complaint(s) from this serial number.

• Brand Name: SITE~RITE 8 REFURB.
• 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: 12013427
• MDR Text Key: 256687744
• Report Number: 3006260740-2021-02345
• Device Sequence Number: 1
• Product Code: IYO
• UDI-Device Identifier: 00801741104138
• UDI-Public: (01)00801741104138
• Combination Product (y/n): N
• PMA/PMN Number: K152554
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 07/27/2021

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: 9770501R
• Device Catalogue Number: 9770501R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2021
• Initial Date Manufacturer Received: 05/26/2021
• Initial Date FDA Received: 06/16/2021
• Supplement Dates Manufacturer Received: 07/27/2021
• Supplement Dates FDA Received: 07/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other