MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 SITE~RITE HALCYON ULTRASOUND SYSTEM; DIAGNOSTIC ULTRASOUND SYSTEM

Catalog Number 950041600

Device Problem Data Problem (3196)

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

Event Date 03/08/2021

Event Type  malfunction  

Manufacturer Narrative

The device has not been received by the manufacturer for evaluation.A history review of serial number 119121267 showed four other similar product complaint(s) from this lot number.The complaints for this lot number have been reported from the same facility.

Event Description

Per biomed - kept giving negative deflection far from the sa node and caused them to get a chest x-rays.Happening with 4-5 different patients.This is for the second of five reported events.

• Brand Name: SITE~RITE HALCYON ULTRASOUND SYSTEM
• Type of Device: DIAGNOSTIC ULTRASOUND SYSTEM
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer Contact: shelly gilbert ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 11610557
• MDR Text Key: 243857077
• Report Number: 3006260740-2021-01128
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170870
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/30/2021

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 Catalogue Number: 950041600
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/08/2021
• Initial Date FDA Received: 04/02/2021
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Other