MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION BODY GUARDIAN MINI PLUS WEARALE CARDIAC MONITOR; DETECTOR AND ALARM, ARRHYTHMIA

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Stryker medical was notified of a potentially reportable complaint involving a product for which stryker is not the original equipment manufacturer of the reported device.The customer alleged a hill-rom and bed, l24am3690, had an inaccurate scale.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: BODY GUARDIAN MINI PLUS WEARALE CARDIAC MONITOR
• Type of Device: DETECTOR AND ALARM, ARRHYTHMIA
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 17534117
• MDR Text Key: 321182754
• Report Number: MW5141019
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1