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

Catalog Number 9770504

Device Problem Sparking (2595)

Patient Problem Shock (2072)

Event Type  malfunction  

Manufacturer Narrative

The information provided by bard 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 bard.The device has not been returned to the manufacturer for evaluation, as the device is being retained by the reporting facility.A lot history review (lhr) of dycvzz515 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (dycvzz515) have been reported from same u.S.Facility.

Event Description

Bd clinical specialist, (b)(6), reported on behalf of account's iv team that the mer stand used with sr 8 ultrasound #(b)(4) is shocking the users each time that they touch the stand.Users also mention that the plug causes a spark each time it is plugged into an outlet.A power strip is not used on the roll stand.Second reported event for this power supply.

• Brand Name: SITE-RITE 8 POWER SUPPLY
• Type of Device: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): DYMAX CORP.; 141 zehner school road; zelienople PA 16063
• Manufacturer Contact: shelly gilbert ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225640
• MDR Report Key: 7936950
• MDR Text Key: 122821425
• Report Number: 3006260740-2018-02745
• Device Sequence Number: 1
• Product Code: IYO
• UDI-Device Identifier: 00801741099496
• UDI-Public: (01)00801741099496
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152554
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 9770504
• Device Lot Number: DYCVZZ515
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 09/12/2018
• 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