• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PHILIPS INTELLIVUE DETECTOR AND ALARM, ARRHYTHMIA

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

PHILIPS MEDICAL SYSTEMS PHILIPS INTELLIVUE DETECTOR AND ALARM, ARRHYTHMIA Back to Search Results
Model Number M4841A
Device Problems Material Erosion (1214); Overheating of Device (1437); Battery Problem (2885); Moisture or Humidity Problem (2986)
Patient Problem Insufficient Information (4580)
Event Date 05/29/2018
Event Type  malfunction  
Event Description
Due to design issues with the philips intellivue telemetry box, including fluid intrusion, the box overheated during patient use. Caregivers then discovered erosion in the battery cage and battery acid leaking out of the unit.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePHILIPS INTELLIVUE
Type of DeviceDETECTOR AND ALARM, ARRHYTHMIA
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
MDR Report Key12672340
MDR Text Key277691406
Report Number12672340
Device Sequence Number1
Product Code DSI
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 10/08/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM4841A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/08/2021
Device Age8 YR
Event Location Hospital
Date Report to Manufacturer10/21/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

-
-