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

Model Number 10116080

Device Problem Computer Software Problem (1112)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 12/04/2021

Event Type  Death  

Manufacturer Narrative

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

Event Description

According to the reporter, the unit had no alarm.The patient passed away.Relationship to the device has not been established at this time.

• 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: avi kluger ; 5920 longbow drive; boulder, CO 80301 ; 3035306582
• MDR Report Key: 13111760
• MDR Text Key: 282918401
• Report Number: 1717344-2021-01699
• 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: Health Professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 12/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2021
• Initial Date FDA Received: 12/29/2021
• 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
• Patient Outcome(s): Death