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

Model Number VITALSYNCSW01

Device Problems Device Alarm System (1012); Computer Software Problem (1112); Labelling, Instructions for Use or Training Problem (1318)

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

Event Date 03/05/2024

Event Type  malfunction  

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

According to the reporter, prior to use, multiple tiles had multiple patients admitted to them and alarms for the current patient did not alert on the tile due to many patients and the alarms were getting pushed out of the tile.It was found out that patients were not getting discharge from the remote surveillance system before new patient was admitted.An internal staff was on the site and patients that were assigned to the same tile were discharged.There was no patient involvement.

Event Description

According to the reporter, during use, multiple tiles had multiple patients admitted to them and alarms for the current patient did not alert on the tile due to many patients and the alarms were getting pushed out of the tile.It was found out that patients were not getting discharge from the remote surveillance system before new patient was admitted.An internal staff was on the site and patients that were assigned to the same tile were discharged.There was no patient injury.

Manufacturer Narrative

New information has been received, and reassessment of the complaint found that it is no longer a reportable event.The event is no longer associated with a serious injury or potential for serious injury with reoccurrence.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: VITAL SYNC
• 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: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 18995495
• MDR Text Key: 338949256
• Report Number: 1717344-2024-00826
• Device Sequence Number: 1
• Product Code: DRG
• UDI-Device Identifier: 10884521780668
• UDI-Public: 10884521780668
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160718
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/29/2024

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: VITALSYNCSW01
• Device Catalogue Number: VITALSYNCSW01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/05/2024
• Initial Date FDA Received: 03/28/2024
• Supplement Dates Manufacturer Received: 04/02/2024
• Supplement Dates FDA Received: 04/29/2024
• 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