MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 MEDICAL EQUIPMENT ROLL STAND; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number N/A

Device Problem Mechanical Problem (1384)

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

Event Date 07/22/2021

Event Type  malfunction  

Manufacturer Narrative

Replacement wheels have been sent to the reporting facility.Therefore, the device will not be returned for evaluation.A history review of serial number asftac015 showed no other similar product complaint(s) from this serial number.Parts-only order.

Event Description

Per biomed, one of the caster wheels will not sit straight and appears to be bent.The stand rocks as the wheels aren't level.

• Brand Name: MEDICAL EQUIPMENT ROLL STAND
• 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: 12277306
• MDR Text Key: 265093665
• Report Number: 3006260740-2021-03124
• Device Sequence Number: 1
• Product Code: IYO
• UDI-Device Identifier: 00801741124693
• UDI-Public: (01)00801741124693
• Combination Product (y/n): N
• PMA/PMN Number: K071204
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial
• Report Date: 07/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 9770116
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/22/2021
• 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