MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SITE-RITE 8 ULTRASUND SYSTEM W/PINPOINT GT SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number 9770501

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

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

Event Type  malfunction  

Manufacturer Narrative

The information provided by bard 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 bard. The manufacturer has received the sample and will be evaluated. Results are expected soon. A history review of serial number (b)(4) showed no other similar complaint(s) from this serial number.

Event Description

Sr 8 ultrasound system shuts down mid-procedure. Battery doesn't seem to be the cause of the loss of power because the system boots to a 50% battery level.

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 unit system shutdown during use was confirmed and the cause is an internal failure in the lithium-ion battery. The scanner was charged to 100%, when the ac adaptor was removed the scanner ran on battery power for approximately 1 hour and shut down with the battery showing a 50% charge. No other functionality issues with the equipment were found during evaluation/servicing. The device was serviced, repaired and returned to the customer. A history review of serial number (b)(4) showed no other similar complaint(s) from this serial number.

Event Description

Sr 8 ultrasound system shuts down mid-procedure. Battery doesn't seem to be the cause of the loss of power because the system boots to a 50% battery level.

• Brand Name: SITE-RITE 8 ULTRASUND SYSTEM W/PINPOINT GT
• Type of Device: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): DYMAX CORP. -2523003; 110 marshall drive; warrendale PA 15086
• Manufacturer Contact: sydney freckleton ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225992
• MDR Report Key: 7613697
• MDR Text Key: 111997595
• Report Number: 3006260740-2018-01431
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152554
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer

Reporter Occupation

• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date: 11/06/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 06/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 9770501
• Device Catalogue Number: 9770501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2018
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: Hospital
• Date Manufacturer Received: 10/11/2019
• 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