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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HEALTHMYNE, INC. HEALTHMYNE QIDS

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HEALTHMYNE, INC. HEALTHMYNE QIDS Back to Search Results
Model Number 3.0
Device Problem Patient Data Problem (3197)
Patient Problem Not Applicable (3189)
Event Date 12/08/2017
Event Type  malfunction  
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 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.
 
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Brand Name
HEALTHMYNE QIDS
Type of Device
HEALTHMYNE QIDS
Manufacturer (Section D)
HEALTHMYNE, INC.
918 deming way
floor 3
madison WI 53717
Manufacturer (Section G)
HEALTHMYNE, INC.
918 deming way
floor 3
madison WI 53717
Manufacturer Contact
sigrid schoepel
918 deming way
floor 3
madison, WI 53717
6084402965
MDR Report Key7264643
MDR Text Key100252056
Report Number3012191385-2017-00001
Device Sequence Number1
Product Code LLZ
UDI-Device IdentifierB198HM0030
UDI-Public+B198HM0030/$$732P
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K153289
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Other
Remedial Action Notification
Type of Report Initial
Report Date 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
Device Operator Other
Device Model Number3.0
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/08/2017
Initial Date FDA Received02/12/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/27/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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