• 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 TELEMON 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 TELEMON DETECTOR AND ALARM, ARRHYTHMIA Back to Search Results
Model Number M2636C
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/06/2016
Event Type  malfunction  
Event Description
The telemetry box pins were broken where it connects to the telemon.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameTELEMON
Type of DeviceDETECTOR AND ALARM, ARRHYTHMIA
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman rd.
andover MA 01810
MDR Report Key6103082
MDR Text Key59936113
Report Number6103082
Device Sequence Number1
Product Code DSI
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Patient
Type of Report Initial
Report Date 08/10/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/15/2016
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM2636C
Other Device ID NumberUS51406881
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/10/2016
Event Location Hospital
Date Report to Manufacturer08/10/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

-
-