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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MMJ SA DE CV (USD) VITAL SYNC REMOTE MONITORING SYSTEM TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY

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MMJ SA DE CV (USD) VITAL SYNC REMOTE MONITORING SYSTEM TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY Back to Search Results
Model Number 10116080
Device Problem Protective Measures Problem (3015)
Patient Problems Death (1802); Insufficient Information (4580)
Event Date 10/19/2020
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, patient had expired and was wondering if the device was alarmed at cns prior to the patient expiring. The nurse said the patient was on camera removing the probe and other monitoring devices.
 
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Brand NameVITAL SYNC REMOTE MONITORING SYSTEM
Type of DeviceTRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY
Manufacturer (Section D)
MMJ SA DE CV (USD)
ave henequen no 1181 desarroll
ciudad juarez 32590
MX 32590
Manufacturer (Section G)
MMJ SA DE CV (USD)
ave henequen no 1181 desarroll
ciudad juarez 32590
MX 32590
Manufacturer Contact
avi kluger
5920 longbow drive
boulder, CO 80301
3035306582
MDR Report Key10816106
MDR Text Key215491831
Report Number2936999-2020-00849
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 company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 06/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/10/2020
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? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/12/2021
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: 11/10/2020 Patient Sequence Number: 1
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