MAUDE Adverse Event Report: AVNET INC VITAL SYNC REMOTE MONITORING SYSTEM; TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY

Model Number 10116080

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Death (1802)

Event Date 03/05/2020

Event Type  Death  

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, the patient died on (b)(6) 2020 and the device had not alarmed and presented the error message "no data for reported parameter".In a follow up phone conversation (b)(6) 2020 with the hospital technician it was clarified that the nurse manager of the orthopedic unit/floor was attempting to gather patient data but was unable to.The tech support team was able to find alarm reports for the dates of (b)(6) 2020 to (b)(6) 2020, but there was no information after that.The vital sync system showed that the patient was "discharged" by a nurse on (b)(6) 2020.They do not believe that the vital sync malfunctioned in any way since the patient was discharged from the vital sync system days prior to the event.

Manufacturer Narrative

Additional information: the information pertaining to the reported event has been reassessed and found not to be a reportable event.According to the reporter they do not believe that the vital sync malfunctioned in any way since the patient was discharged from the vital sync system days prior to the event.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.

• Brand Name: VITAL SYNC REMOTE MONITORING SYSTEM
• Type of Device: TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY
• Manufacturer (Section D): AVNET INC; 2740 american blvd w, ste 150; bloomington MN 55431
• MDR Report Key: 9900478
• MDR Text Key: 185600978
• Report Number: 2936999-2020-00234
• Device Sequence Number: 1
• Product Code: DRG
• Combination Product (y/n): N
• PMA/PMN Number: K093422
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 06/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10116080
• Device Catalogue Number: 10116080
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death