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

Model Number 9770501

Device Problems Intermittent Continuity (1121); Battery Problem (2885); Power Problem (3010)

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

Event Type  malfunction  

Manufacturer Narrative

The device has not been received by the manufacturer, at this time, for evaluation.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.Device has not been received, at this time.

Event Description

Per iv team: machine shuts off while battery is fully charged.Will not turn back on until plugged in.

Event Description

Per iv team: machine shuts off while battery is fully charged.Will not turn back on until plugged in.

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 the machine shuts off while battery is fully charged is confirmed.The scanner shuts off when not plugged in and fully charged.The root cause of the reported issue is a bad li-ion battery no other functionality issues with the equipment were found during evaluation/servicing.The device was serviced, tested and returned to the customer.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.

Manufacturer Narrative

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 machine shuts off while battery is fully charged is confirmed.The scanner shuts off when not plugged in and fully charged.The root cause of the reported issue is a bad li-ion battery no other functionality issues with the equipment were found during evaluation/servicing.The device was serviced, tested and returned to the customer.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 iv team: machine shuts off while battery is fully charged.Will not turn back on until plugged in.

• 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: 8323613
• MDR Text Key: 135879717
• Report Number: 3006260740-2019-00214
• 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: 11/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2019
• 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: 03/07/2019
• Event Location: Hospital
• Date Manufacturer Received: 05/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 2243072-10/11/2019-013-C
• Patient Sequence Number: 1