MAUDE Adverse Event Report: REFURB, SR PREVUE PLUS; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number 9770086R

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

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 tm- the screen is cracked, which interferes with viewing vessel for successful insertion.

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 fmea documents, labeling and applicable manufacture records.Based on a review of this information, the following as concluded: the device was returned to the service facility for evaluation.During evaluation, the reported issue of screen is cracked was confirmed.The scanner was inspected the display is cracked, the cause of the issue is due to use-related damage, causing the scanner to have a partial screen.A history review of serial number (b)(6) showed no other similar product complaint(s) from this serial number.

Event Description

Per tm- the screen is cracked, which interferes with viewing vessel for successful insertion.

• Brand Name: REFURB, SR PREVUE PLUS
• Type of Device: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• MDR Report Key: 9373469
• MDR Text Key: 168467600
• Report Number: 3006260740-2019-03700
• Device Sequence Number: 1
• Product Code: IYO
• UDI-Device Identifier: 00801741124945
• UDI-Public: (01)00801741124945
• Combination Product (y/n): N
• PMA/PMN Number: K120882
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9770086R
• Device Catalogue Number: 9770086R
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2019
• Event Location: Hospital
• Date Manufacturer Received: 04/18/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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