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

Catalog Number 950041600

Device Problems No Apparent Adverse Event (3189); 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 (b)(4) 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 first of five reported events.

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 inaccurate ecg readings was unconfirmed.The service center confirmed expected functionality of the halcyon system with up-to-date software version.Vad engineering analysis could not duplicate the inaccurate readings during evaluation.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 four other similar product complaint(s) from this lot number.The complaints for this lot number have been reported from the same facility.H3 other text : evaluation findings are in section h.11.

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.

• 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
• MDR Report Key: 11610524
• MDR Text Key: 243730362
• Report Number: 3006260740-2021-01127
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• PMA/PMN Number: K170870
• 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: 06/04/2021

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2021
• Initial Date Manufacturer Received: 03/08/2021
• Initial Date FDA Received: 04/02/2021
• Supplement Dates Manufacturer Received: 06/04/2021
• Supplement Dates FDA Received: 06/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other