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

Model Number 9770500

Device Problems Loss of Power (1475); Battery Problem (2885)

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.Device has not been received, at this time.

Event Description

Per picc rn, battery has shut off during procedure twice.This is for the first event reported.

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 battery has shut off during procedure twice.The sr8 was received in good physical condition.The sr8 was powered on at 98% battery life and ran for around one hour before shutting down with 62% battery life still on the scanner.The device was serviced, tested, and returned to the customer.A history review of serial number (b)(6) showed no other similar product complaint(s) from this serial number.

Event Description

Per picc registered nurse, battery has shut off during procedure twice.This is for the first event reported.

• Brand Name: SITE-RITE 8 ULTRASOUND
• Type of Device: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• MDR Report Key: 9470146
• MDR Text Key: 175105350
• Report Number: 3006260740-2019-03865
• Device Sequence Number: 1
• Product Code: IYO
• UDI-Device Identifier: 00801741096891
• UDI-Public: (01)00801741096891
• 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
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 04/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9770500
• Device Catalogue Number: 9770500
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2020
• Event Location: Hospital
• Date Manufacturer Received: 04/13/2020
• 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
• Removal/Correction Number: 2243072-10/11/2019-013-C
• Patient Sequence Number: 1