MAUDE Adverse Event Report: SITE-RITE 8 ULTRASOUND; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number 9770501

Device Problem Application Program Freezes, Becomes Nonfunctional (4031)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The manufacturer has received the sample and will be evaluated.A supplemental will be submitted with evaluation results.A history review of serial number (b)(4) showed no other similar product complaint(s) from this serial number.

Event Description

Per biomed, system has frozen in two different procedures.This file is for the second of two reported events.

Event Description

Per biomed, system has frozen in two different procedures.This file is for the first of two 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 initial medwatch indicated the unit had been received, and evaluation conclusion would be documented in this supplemental.Because there were two events reported on one unit no evaluation conclusion will be submitted in this supplemental.The for evaluation for the unit will be submitted on mdr number: 3006260740-2019-03949.

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 system has frozen in two different procedures is unconfirmed.The root cause of the reported issue could not be reproduced during evaluation.The device was serviced, tested and returned to the customer.

Event Description

Per biomed, system has frozen in two different procedures.This file is for the second of two reported events.

• Brand Name: SITE-RITE 8 ULTRASOUND
• Type of Device: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• MDR Report Key: 9496877
• MDR Text Key: 176684749
• Report Number: 3006260740-2019-03949
• Device Sequence Number: 1
• Product Code: IYO
• UDI-Device Identifier: 00801741098338
• UDI-Public: (01)00801741098338
• 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,Followup
• Report Date: 04/30/2020

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 Model Number: 9770501
• Device Catalogue Number: 9770501
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2019
• Event Location: Hospital
• Initial Date Manufacturer Received: 11/25/2019
• Initial Date FDA Received: 12/19/2019
• Supplement Dates Manufacturer Received: 04/08/2020; 04/08/2020
• Supplement Dates FDA Received: 04/30/2020; 04/30/2020
• 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