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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER VITAL SYNC REMOTE MONITORING SYSTEM TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY

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COVIDIEN MFG DC BOULDER VITAL SYNC REMOTE MONITORING SYSTEM TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY Back to Search Results
Model Number 10116080
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Death (1802); Insufficient Information (4580)
Event Date 08/31/2020
Event Type  Death  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, the patient expired while being monitored by the device. It was stated that the device did not alarm. Upon examination of the patient data, the alarms were functioning as expected, data including spo2 and pulse rate were gathered and provided to the hospital staff. The device examined and data indicated that the alarms were not silenced on the time of incident. The hospital staff were trying to determine why the device's alarm were not acted upon.
 
Manufacturer Narrative
Evaluation summary: medtronic conducted an investigation based upon all information received. The device was available for evaluation. The evaluation found that vs alarms were functioning as expected, and the vital sync data indicated that vital sync alarms were not silenced during this period. It was reported that there was an adverse event but no rgi medtronic product was implicated in the event. A potentially related device issue could not be confirmed. The most likely cause could not be established from the information available. The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameVITAL SYNC REMOTE MONITORING SYSTEM
Type of DeviceTRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY
Manufacturer (Section D)
COVIDIEN MFG DC BOULDER
5920 longbow dr
boulder CO 80301 3299
Manufacturer (Section G)
COVIDIEN MFG DC BOULDER
5920 longbow dr
boulder CO 80301 3299
Manufacturer Contact
avi kluger
5920 longbow drive
boulder, CO 80301
3035306582
MDR Report Key10582920
MDR Text Key208425969
Report Number2936999-2020-00693
Device Sequence Number1
Product Code DRG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K093422
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/24/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number10116080
Device Catalogue Number10116080
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/04/2020
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 Unkown

Patient Treatment Data
Date Received: 09/24/2020 Patient Sequence Number: 1
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