MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 SITE-RITE 8 ULTRASOUND; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number 9770500

Device Problems Defective Component (2292); Unexpected Shutdown (4019)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/27/2021

Event Type  malfunction  

Manufacturer Narrative

The manufacturer has received the sample and will be evaluated.A supplemental will be submitted with evaluation results.A history review of serial number (b)(4) showed one similar complaint from this serial number.The similar complaints have been reported by the same us facility.The previous complaint evaluations for this serial number ((b)(4)) is: confirmed, root cause was identified as a failure on the lithium-ion battery.(reference: mdr number 3006260740-2019-01805).

Event Description

It was reported the device randomly shuts off after it reaches 75% battery.

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 the unit shuts off was confirmed.The unit abruptly shuts off when not connected to ac power.The root cause of the failure was identified as an internal failure within the lithium-ion battery.A history review of serial number dybnac043 showed one similar complaint from this serial number.The similar complaints have been reported by the same us facility.The previous complaint evaluations for this serial number (dybnac043) is: confirmed, root cause was identified as a failure on the lithium-ion battery.(reference: mdr number 3006260740-2019-01805).

Event Description

It was reported the device randomly shuts off after it reaches 75% battery.

• Brand Name: SITE-RITE 8 ULTRASOUND
• Type of Device: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 11351016
• MDR Text Key: 234212581
• Report Number: 3006260740-2021-00403
• Device Sequence Number: 1
• Product Code: IYO
• UDI-Device Identifier: 00801741096891
• UDI-Public: (01)00801741096891
• Combination Product (y/n): N
• PMA/PMN Number: K152554
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 05/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9770500
• Device Catalogue Number: 9770500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2021
• Date Manufacturer Received: 05/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 2243072-10/11/2019-013-C
• Patient Sequence Number: 1
• Patient Outcome(s): Other