MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SITE~RITE 8 ULTRASOUND SYSTEM; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Catalog Number 9770550

Device Problems Loss of Power (1475); Failure to Power Up (1476); Battery Problem (2885); Unexpected Shutdown (4019)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The device has not been received by the manufacturer, at this time, for evaluation.A lot history review (lhr) review is not possible, as the device is manufactured using a unique serial number and not by lot number.A history review of serial number (b)(4) showed no other similar product complaint(s) from this serial number.

Event Description

It was reported the system turns on and off alone.There are times that neither turns on.

Manufacturer Narrative

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 turning on and off without warning was confirmed.The root cause of the failure was identified as a faulty main board.No other functionality issues with the equipment were found during evaluation/servicing.The device was serviced, tested, and returned to the customer.A history review of serial number (b)(4) showed no other similar product complaint(s) from this serial number.

Event Description

It was reported the system turns on and off alone.There are times that neither turns on.

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 turning on and off without warning was confirmed.The root cause of the failure was identified as a faulty main board.No other functionality issues with the equipment were found during evaluation/servicing.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

It was reported the system turns on and off alone.There are times that neither turns on.

• Brand Name: SITE~RITE 8 ULTRASOUND SYSTEM
• Type of Device: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8677158
• MDR Text Key: 147306629
• Report Number: 3006260740-2019-01583
• Device Sequence Number: 1
• Product Code: IYO
• UDI-Device Identifier: 00801741098208
• UDI-Public: (01)00801741098208
• 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,user f
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date: 11/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9770550
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2019
• Event Location: Hospital
• Date Manufacturer Received: 10/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 2243072-10/11/2019-013-C
• Patient Sequence Number: 1