MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SITE~RITE 8 ULTRASOUND SYSTEM 20 MM PINPOINT GT; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number 9770602

Device Problems Signal Artifact/Noise (1036); Defective Component (2292); Output Problem (3005)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The device has not been received by the manufacturer, at this time, for evaluation.A history review of serial number (b)(4), showed no other similar product complaint(s) from this serial number.

Event Description

Per biomed-the probe is faulty and causing artifacts.

Event Description

Per biomed-the probe is faulty and causing artifacts.

Manufacturer Narrative

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 artifacts in the probe image is confirmed.The probe displays 'artifacts' on the ultrasound image.The root cause of the reported issue is an internal probe failure.No other functionality issues with the equipment were found during evaluation/servicing.The device was discarded due to being irreparable.A history review of serial number (b)(4) showed no other similar product complaint(s) from this serial number.

• Brand Name: SITE~RITE 8 ULTRASOUND SYSTEM 20 MM PINPOINT GT
• Type of Device: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8781774
• MDR Text Key: 150823434
• Report Number: 3006260740-2019-01922
• Device Sequence Number: 1
• Product Code: IYO
• UDI-Device Identifier: 00801741138324
• UDI-Public: (01)00801741138324
• Combination Product (y/n): N
• PMA/PMN Number: K152554
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 11/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9770602
• Device Catalogue Number: 9770602
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2019
• Event Location: Hospital
• Date Manufacturer Received: 10/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1