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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 No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/14/2022
Event Type  malfunction  
Manufacturer Narrative
Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803. This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda. Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report. This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report. In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿. These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting. Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms. This statement should be included with any information or report disclosed to the public under the freedom of information act. Any required fields that are unpopulated are blank because the information is currently unknown or unavailable. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, prior to use, when using https, the alarm silence button on the remote surveillance system was not visible for medium and low priority alarms. These alarms showed when http was used. There was visual alarm but no auditory alarm. No error was visible in any logs. The development team had to produce a patch to resolve the issue. There was no patient involvement.
 
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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
justin ellis
8200 coral sea st ne
mounds view, MN 55112
7635265677
MDR Report Key15250107
MDR Text Key298151777
Report Number1717344-2022-00993
Device Sequence Number1
Product Code DRG
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/21/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/18/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number10116080
Device Catalogue Number10116080
Device Lot NumberVPMP 2.10 10884521
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received10/06/2022
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

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