MAUDE Adverse Event Report: SITE~RITE 8 ULTRASOUND SYSTEM 32 MM LINEAR PROBE; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number 9770601

Device Problem Failure to Align (2522)

Patient Problem No Consequences Or Impact To Patient (2199)

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, probe not matching center lines on sr8.

Event Description

Per tm, probe not matching center lines on sr8.

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 probe not matching center lines on sr8 and blurry image was unconfirmed.The root cause of the reported failure is inconclusive as the reported issue could not be reproduced during evaluation.The site rite 8 32mm probe was visually inspected upon receipt and was found to be in good physical condition.The image is comparable to the house test probe.A history review of serial number dydrag553 showed no other similar product complaint(s) from this serial number.

• Brand Name: SITE~RITE 8 ULTRASOUND SYSTEM 32 MM LINEAR PROBE
• Type of Device: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• MDR Report Key: 10137550
• MDR Text Key: 194620006
• Report Number: 3006260740-2020-02023
• Device Sequence Number: 1
• Product Code: IYO
• UDI-Device Identifier: 00801741138294
• UDI-Public: (01)00801741138294
• Combination Product (y/n): N
• PMA/PMN Number: K152554
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 08/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9770601
• Device Catalogue Number: 9770601
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2020
• Event Location: Hospital
• Date Manufacturer Received: 07/28/2020
• 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