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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HILL-ROM CARY WAVE CLINICAL PLATFORM; MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS)

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HILL-ROM CARY WAVE CLINICAL PLATFORM; MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS) Back to Search Results
Device Problem Device Alarm System (1012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/25/2023
Event Type  malfunction  
Event Description
Hillrom received a report from a hillrom technician stating the staff who were already logged into the system tried to send a code and received a 404 error.Staff were also logged out which caused delays in sending codes.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint # (b)(4).
 
Manufacturer Narrative
The hillrom technician found the wave was not correctly configured.The wave clinical platform is software intended to route, store, and display data, alarms, results and diagnostic information from medical devices, electronic medical records (emr), and clinical information systems (cis).The wave clinical platform is a remote monitoring platform that displays physiologic data, waveforms, alarms, results and diagnostic information routed through the platform from supported devices and systems.The wave clinical platform is intended for use in hospital or hospital type environments.The wave clinical platform is intended to be used by healthcare professionals for the following purposes: ¿ to remotely consult regarding patients¿ statuses; ¿ to remotely review other standard or critical near real-time patient data, waveforms, alarms, and results in order to utilize this information to aid in clinical decisions.The user manual contains warnings such as "the wave clinical platform is intended to supplement and not replace any part of the hospital's device monitoring or electronic data management systems.Do not rely on the wave clinical platform product as the sole source of alarms".The hrc technician arranged to get it configured for the customer to resolve the issue.Although there was no injury associated with this event, if the reported issue were to recur it could lead to injury or death.Therefore hillrom is reporting this complaint.
 
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Brand Name
WAVE CLINICAL PLATFORM
Type of Device
MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS)
Manufacturer (Section D)
HILL-ROM CARY
1225 crescent green dr., suite 300
cary NC 27518
Manufacturer Contact
estephania cardenas
1225 crescent green dr., suite 300
cary, NC 27518
8129310130
MDR Report Key17785869
MDR Text Key323910006
Report Number2027454-2023-00078
Device Sequence Number1
Product Code MWI
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 09/20/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/20/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received08/25/2023
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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