MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SITE~RITE 6 ULTRASOUND SYSTEM BEDSIDE VAD ROLL STAND; ULTRASOUND PULSED ECHO IMAGING SYSTEM; DIAGNOSTIC ULTRASONIC TRANSDUCERS

Model Number N/A

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Electric Shock (2554)

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 manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

Event Description

Facility stated that it was reported by the picc rn's that they receive a hard electric shock when using the site rite 6 attached to a gcx stand.Images show that the stand has been modified with unidentified equipment and a power strip.

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 following were reviewed as part of this investigation: patient severity, trend analysis, 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 root cause of the reported complaint regarding electric shock is inconclusive as evaluation of the photo sample indicates that the roll stand has been modified by the user.Root cause of the shock could not be definitively determined without physical evaluation of the equipment.Manufacturing records for the scanner were also reviewed and no potential contributing factors were found during manufacture and quality inspection of the scanner a lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

Event Description

Facility stated that it was reported by the picc rn's that they receive a hard electric shock when using the site rite 6 attached to a gcx stand.Images show that the stand has been modified with unidentified equipment and a power strip.

• Brand Name: SITE~RITE 6 ULTRASOUND SYSTEM BEDSIDE VAD ROLL STAND
• Type of Device: ULTRASOUND PULSED ECHO IMAGING SYSTEM; DIAGNOSTIC ULTRASONIC TRANSDUCERS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): DYMAX CORP. -2523003; 110 marshall drive; warrendale PA 15086
• Manufacturer Contact: kelsey erickson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225937
• MDR Report Key: 6784255
• MDR Text Key: 82771407
• Report Number: 3006260740-2017-01261
• Device Sequence Number: 1
• Product Code: IYO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071204
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2017
• 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: 9772001
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 02/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1