MAUDE Adverse Event Report: HITACHI, LTD. HEALTHCARE TOKYO WORKS NOBLUS ULTRASOUND SCANNER; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Device Problems Loss of or Failure to Bond (1068); Break (1069); Solder Joint Fracture (2324); Material Integrity Problem (2978)

Patient Problem No Patient Involvement (2645)

Event Date 12/09/2016

Event Type  malfunction  

Manufacturer Narrative

Noblus # (b)(4) (ac adapter # (b)(4)) in cardiac office.Ac power adapter manufacturing address as follows, (b)(4).The ac power adaptor used with the noblus (k142368) ultrasound system is an "out of the box/off the shelf" external power supply.The noblus was not affected by the failure of the ac power adapter.There was no patient or user injury and once a replacement ac power adapter was put into place the nobluse functioned per specification.(b)(4).

Event Description

One (1) ac power adapter(s) - (ac adapter serial # (b)(4)) with noblus serial # (b)(4)) smoldered, smoked and partially damage to both power adapters.No damage to the ultrasound systems, both unites were unaffected and meet specifications.No patient or user injury.Manufacturer (xp power (kunshan) ltd.) is currently investigating root cause of failure.

• Brand Name: NOBLUS ULTRASOUND SCANNER
• Type of Device: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• Manufacturer (Section G): HITACHI, LTD. HEALTHCARE TOKYO WORKS; 3-7-19, imai, ome-shi; tokyo, 198-8 577; JA 198-8577
• Manufacturer Contact: angela van arsdale ; 10 fairfield blvd.; wallingford, CT 06492-5903 ; 2032696088
• MDR Report Key: 6446683
• MDR Text Key: 71586776
• Report Number: 9610865-2016-00001
• Device Sequence Number: 1
• Product Code: IYO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142368
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 01/05/2017

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: No Information
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2016
• Distributor Facility Aware Date: 12/09/2016
• Event Location: Outpatient Treatment Facility
• Initial Date Manufacturer Received: 12/09/2016
• Initial Date FDA Received: 03/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/06/2014
• 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