MAUDE Adverse Event Report: HITACHI LTD, HEALTHCARE TOKYO WORKS PROSOUND F37; ULTRASONIC PULSED ECHO IMAGING SYSTEM

Model Number PROSOUND F37

Device Problems Device Issue (2379); Device Operational Issue (2914); Compatibility Problem (2960); Measurement System Incompatibility (2982)

Patient Problems Congenital Defect/Deformity (1782); Patient Problem/Medical Problem (2688)

Event Date 03/16/2016

Event Type  Injury  

Manufacturer Narrative

The f37 has a programmable ob report and the doctor was not aware of the default programming of the estimated fetal weight percentile parameter.Hitachi confirmed that the discrepancy between the system and the website was due to the fact that they were not using the same calculation tables.The f37 was programmed to display doubilet efw values, while the website estimated the efw percentile using hadlock calculation tables.The physician did not report any other issues with the displayed ob report, which displays many other weight, height, and age estimates.Device evaluated by mfr: eval use conditions confirmed at office.

Event Description

On (b)(6) 2016, a facility reported an adverse event involving the hitachi prosound f37 ultrasound system.The physician emailed the company and claimed that "comparing the measurements with the percentiles on (b)(4), the numbers from the f37 machine are off." she also stated that "they had a patient with a dead baby last month." the patient had an ultrasound a few days before the baby was dead.The u.S machine reported 24% for weight, but (b)(4) reported 6% for the same data.A 6% reading would have prompted a referral as soon as possible.She noted both measurement tools use hadlock method.

• Brand Name: PROSOUND F37
• Type of Device: ULTRASONIC PULSED ECHO IMAGING SYSTEM
• Manufacturer (Section D): HITACHI LTD, HEALTHCARE TOKYO WORKS; 3-7-19 imai; ome-shi, tokyo 198-8 577; JA 198-8577
• Manufacturer (Section G): HITACHI LTD. HEALTHCARE TOKYO WORKS; 3-7-19 imai; ome-shi, tokyo 19885 77; JA 1988577
• Manufacturer Contact: angela van ardsdale ; 10 fairfield blvd.; wallingford, CT 06492 ; 2032695088
• MDR Report Key: 6449984
• MDR Text Key: 71457660
• Report Number: 9610865-2016-00002
• Device Sequence Number: 1
• Product Code: IYO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122341
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other Health Care Professional
• Device Model Number: PROSOUND F37
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/28/2015
• 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): Congenital Anomaly