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

Model Number 9770600Y

Device Problem Application Program Freezes, Becomes Nonfunctional (4031)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/07/2021

Event Type  malfunction  

Manufacturer Narrative

The device has not been received by the manufacturer for evaluation.A history review of serial number (b)(4) showed one similar complaint from this serial number.The similar complaint has been reported by the same us facility.The previous complaint evaluation for this serial number ((b)(4)) are: unconfirmed as the failure could not be reproduced during evaluation.(reference: mdr number (b)(4)).

Event Description

Per biomed - unit intermittently freezing up.

• Brand Name: SITE-RITE 8 ULTRASOUND SYSTEM CONSOLE (REMANUFACTURED)
• 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: 12241355
• MDR Text Key: 264049059
• Report Number: 3006260740-2021-02971
• Device Sequence Number: 1
• Product Code: IYO
• UDI-Device Identifier: 00801741138287
• UDI-Public: (01)00801741138287
• 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
• Type of Report: Initial
• Report Date: 07/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9770600Y
• Device Catalogue Number: 9770600Y
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/07/2021
• Initial Date FDA Received: 07/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other