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

Model Number 10116080

Device Problems Computer Software Problem (1112); Communication or Transmission Problem (2896)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/11/2022

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, prior to use, the remote surveillance system was stuck on connecting to the server and the audio was not working.The user was guided on how to resolve the issue by going through the services to get the server back up and running.The server was rebooted to get the system working again.The audio did not work after multiple attempts.An external speaker was used to provide the audio.There was no patient involvement.

• Brand Name: VITAL SYNC REMOTE MONITORING SYSTEM
• Type of Device: TRANSMITTERS 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: clay chandler ; 5920 longbow drive; boulder, CO 80301 ; 3035306409
• MDR Report Key: 14545249
• MDR Text Key: 293153541
• Report Number: 1717344-2022-00658
• Device Sequence Number: 1
• Product Code: DRG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093422
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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
• Initial Date Manufacturer Received: 05/11/2022
• Initial Date FDA Received: 05/30/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1