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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 SIGN

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COVIDIEN MFG DC BOULDER VITAL SYNC REMOTE MONITORING SYSTEM TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGN Back to Search Results
Model Number 10116080
Device Problem Computer Software Problem (1112)
Patient Problem Unspecified Tissue Injury (4559)
Event Date 12/04/2021
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 unit had no alarm. The patient passed away. Relationship to the device has not been established at this time.
 
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Brand NameVITAL SYNC REMOTE MONITORING SYSTEM
Type of DeviceTRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGN
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 Key13111760
MDR Text Key282918401
Report Number1717344-2021-01699
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 Health Professional
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 12/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2021
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? Yes
Date Manufacturer Received12/06/2021
Was Device Evaluated by Manufacturer? No Answer Provided
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: 12/29/2021 Patient Sequence Number: 1
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