MAUDE Adverse Event Report: HEALTHMYNE, INC. HEALTHMYNE QIDS

Model Number	3.0
Medical Device Problem Code	Patient Data Problem (3197)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	12/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The hl7 standard and ihe testing for the standard combine to state that the pid fields which contain patient identifiers are expected to contain unique identifying information in the first 15 digits of the field, a carat separator, then 4 digits for an assigning authority (typically a facility id), for a total of 20 digits per pid (there are three: pid 2, pid 3, pid 4).In keeping with the hl7 standard and ihe guidelines/testing parameters, healthmyne identifies patients based on the first 15 digits of the pid fields.If a facility uses all 20 digits as the unique identifying information and the digits that uniquely identify the patient are within the last five digits, multiple patients could be merged together as one patient in healthmyne.This is only a problem if healthmyne is receiving malformed hl7 pids per the ihe guidelines/testing parameters.Healthmyne parses the field without checking it for conformance.Future releases will be enhanced to check for malformed/non-conforming patient id fields to flag and contain them to prevent their use until the malformation or non-conformance is addressed by the facility.All customers have been contacted and checked.This occurred at only one customer with a subset of studies, & none of the studies were accessed for interpretation.
Event or Problem Description
Malformed hl7 patient ids were sent to this medical device resulting in different patient's studies being identified as the same patient.None of these studies were read or used for diagnosis.The issue was discovered during a routine service check, customer was contacted, and the issue was contained.

• Brand Name: HEALTHMYNE QIDS
• Common Device Name: HEALTHMYNE QIDS
• Manufacturer (Section D): HEALTHMYNE, INC.; 918 deming way; floor 3; madison WI 53717
• MDR Report Key: 7264643
• Report Number: 3012191385-2017-00001
• Device Sequence Number: 19289459
• Product Code: LLZ
• UDI-Device Identifier: B198HM0030
• UDI-Public: +B198HM0030/$$732P
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K153289
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 12/08/2017

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
• Operator of Device: Other
• Device Model Number: 3.0
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2017
• Initial Report FDA Received Date: 02/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1