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

Model Number	VITALSYNCSW01
Medical Device Problem Codes	Device Alarm System (1012); Computer Software Problem (1112); Labelling, Instructions for Use or Training Problem (1318)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2024
Type of Reportable Event	Malfunction
Additional 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 or Problem 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 or Problem 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.
Additional 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.
Additional Manufacturer Narrative
Additional information: h6 correction: g3 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
• Common Device Name: 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
• Report Number: 1717344-2024-00826
• Device Sequence Number: 2946397
• Product Code: DRG
• UDI-Device Identifier: 10884521780668
• UDI-Public: 10884521780668
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K160718
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/02/2024

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
• Operator of Device: Health Professional
• Device Model Number: VITALSYNCSW01
• Device Catalogue Number: VITALSYNCSW01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2024
• Supplement Date Received by Manufacturer: 04/02/2024; 03/22/2024
• Initial Report FDA Received Date: 03/28/2024
• Supplement Report FDA Received Date: 04/29/2024; 10/02/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown