MAUDE Adverse Event Report: SITE~RITE 8 ULTRASOUND SYSTEM 20 MM CUE LINEAR; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number 9770603

Device Problems Break (1069); Defective Component (2292); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/11/2021

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, the image has "drop outs", damaged crystals.

Event Description

Per biomed, the image has "drop outs", damaged crystals.

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 the image has "drop outs" was confirmed; the image shows a few black lines running down vertically.The root cause of the reported failure was identified as a probe failure.A history review of serial number (b)(6) showed no other similar product complaint(s) from this serial number.

• Brand Name: SITE~RITE 8 ULTRASOUND SYSTEM 20 MM CUE LINEAR
• Type of Device: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• MDR Report Key: 11281172
• MDR Text Key: 231411166
• Report Number: 3006260740-2021-00223
• Device Sequence Number: 1
• Product Code: IYO
• UDI-Device Identifier: 00801741138218
• UDI-Public: (01)00801741138218
• Combination Product (y/n): N
• PMA/PMN Number: K182281
• 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: 06/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9770603
• Device Catalogue Number: 9770603
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2021
• Date Manufacturer Received: 06/07/2021
• 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