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

Model Number 9770501

Device Problems Battery Problem (2885); Unintended Application Program Shut Down (4032)

Patient Problems No Consequences Or Impact To Patient (2199); 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 tm: the machine will show like 59% and then shut off.They feel like if it isn't plugged in then it will randomly power off.

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 shutting down was confirmed.The sr8 was fully charged and ran on battery power for around 20 minutes before shutting down with 87% battery life left.The root cause of the failure was identified as a failure in the internal battery.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

Per tm: the machine will show like 59% and then shut off.They feel like if it isn't plugged in then it will randomly power off.

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 shutting down was confirmed.The sr8 was fully charged and ran on battery power for around 20 minutes before shutting down with 87% battery life left.The root cause of the failure was identified as a failure in the internal battery.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 tm: the machine will show like 59% and then shut off.They feel like if it isn't plugged in then it will randomly power off.

• 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: 8551961
• MDR Text Key: 143715780
• Report Number: 3006260740-2019-01169
• 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
• 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: 04/25/2019
• 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
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2019
• 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