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

Catalog Number 9770233

Device Problems Defective Component (2292); Output Problem (3005)

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

Event Date 02/05/2021

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

Clinical staff reported that shallow depth only shows artifact on screen.

Event Description

Clinical staff reported that shallow depth only shows artifact on 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 this information, the following was concluded: the device was returned to the service facility for evaluation.During evaluation, the reported issue of poor image quality was confirmed.The ultrasound image displays ¿rain¿ or interference.The root cause of the failure was identified as the beamformer board.A history review of serial number (b)(6) showed no other similar product complaint(s) from this serial number.H3 other text : evaluation findings are in section h.11.

• Brand Name: SITE~RITE 8 PREVUE ULTRASOUND SYSTEM
• 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: 11389007
• MDR Text Key: 238864392
• Report Number: 3006260740-2021-00550
• Device Sequence Number: 1
• Product Code: IYO
• Combination Product (y/n): N
• PMA/PMN Number: K150529
• 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: 05/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9770233
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2021
• Date Manufacturer Received: 05/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other