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); Protective Measures Problem (3015)

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

Event Date 03/03/2022

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 had no alarm.The audio was re-enabled on the system to resolve the issue.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: 13830969
• MDR Text Key: 287521587
• Report Number: 1717344-2022-00325
• Device Sequence Number: 1
• Product Code: DRG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2022
• 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
• Date Manufacturer Received: 03/03/2022
• 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