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

Model Number 9770501

Device Problems Battery Problem (2885); Intermittent Loss of Power (4016)

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 history review of serial number (b)(4) showed no other similar complaint(s) from this serial number.

Event Description

Biomed reported the system shuts down without warning when running on battery.It has shut down in a procedure with 90% battery charge indicated.

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 biomed reported the system shuts down without warning when running on battery.It has shut down in a procedure with 90% battery charge indicated was confirmed.The scanner was charged to 100%, when the ac adaptor was removed the scanner ran on battery power for approximately 10 minutes.The device was serviced, tested, 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

Biomed reported the system shuts down without warning when running on battery.It has shut down in a procedure with 90% battery charge indicated.

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 biomed reported the system shuts down without warning when running on battery.It has shut down in a procedure with 90% battery charge indicated.Was confirmed.The scanner was charged to 100%, when the ac adaptor was removed the scanner ran on battery power for approximately 10 minutes.The device was serviced, tested, 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

Biomed reported the system shuts down without warning when running on battery.It has shut down in a procedure with 90% battery charge indicated.

• Brand Name: SITE-RITE 8 ULTRASOUND 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
• MDR Report Key: 8103917
• MDR Text Key: 128599149
• Report Number: 3006260740-2018-03401
• 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: 11/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2018
• 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: 11/21/2018
• 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