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

Model Number 9770501

Device Problem Failure to Charge (1085)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The manufacturer has received the sample and will be evaluated.Results are expected soon.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

Per customer: the battery does not hold a charge.We've noticed that "after it had been charging overnight after we unplug it about half hour after that the battery will be 1-2% so we need to plug it again while we are doing the picc and it needs to be plugged to a red outlet otherwise it won't charge or it will charge very slow.It does not shut down because we catch it when it is 1%.Yes, the battery indicates a full charge after it's charging for a long time.Yes, the green battery with lightning bolt on top comes on when it's plugged.".

Event Description

Per customer: the battery does not hold a charge.We've noticed that "after it had been charging overnight after we unplug it about half hour after that the battery will be 1-2% so we need to plug it again while we are doing the picc and it needs to be plugged to a red outlet otherwise it won't charge or it will charge very slow.It does not shut down because we catch it when it is 1%.Yes, the battery indicates a full charge after it's charging for a long time.Yes, the green battery with lightning bolt on top comes on when it's plugged.".

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 battery does not hold a charge was confirmed.During inspection the scanner will shut down after power supply is unplugged when one hundred charged, the cause of the reported issue is an internal li-ion battery failure, causing the premature discharge of the battery.The device was serviced, tested, and returned to the customer.A history review of serial number dyazac043 showed no other similar product complaint(s) from this serial number.

• Brand Name: SITE-RITE 8 ULTRASOUND
• 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: 8484609
• MDR Text Key: 141091105
• Report Number: 3006260740-2019-00784
• Device Sequence Number: 1
• Product Code: IYO
• UDI-Device Identifier: 00801741098338
• UDI-Public: (01)00801741098338
• 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
• Type of Report: Initial,Followup
• Report Date: 07/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9770501
• Device Catalogue Number: 9770501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2019
• Date Manufacturer Received: 06/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1