MAUDE Adverse Event Report: SITE~RITE 8 PREVUE PLUS; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number 9770086

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/22/2020

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 no other similar product complaint(s) from this serial number.

Event Description

Per tm, the screen flips/inverts during use on patients as if the probe is recognizing a gel cap--the facility does not use gel caps.

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 detection of gel caps was unconfirmed.There is no gel cap message on the screen and the console displayed proper screen orientation through the assessment of the device.The gel cap message only appears when the option is selected in the settings.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 dyawq034 showed no other similar product complaint(s) from this serial number.H3 other text : evaluation findings are in section h.11.

Event Description

Per tm, the screen flips/inverts during use on patients as if the probe is recognizing a gel cap--the facility does not use gel caps.

• Brand Name: SITE~RITE 8 PREVUE PLUS
• Type of Device: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• MDR Report Key: 10764722
• MDR Text Key: 215338255
• Report Number: 3006260740-2020-20319
• Device Sequence Number: 1
• Product Code: IYO
• UDI-Device Identifier: 00801741095450
• UDI-Public: (01)00801741095450
• 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,other
• Type of Report: Initial,Followup
• Report Date: 12/22/2020

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: 9770086
• Device Catalogue Number: 9770086
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2020
• Initial Date Manufacturer Received: 10/06/2020
• Initial Date FDA Received: 10/30/2020
• Supplement Dates Manufacturer Received: 12/22/2020
• Supplement Dates FDA Received: 01/21/2021
• 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
• Patient Outcome(s): Other