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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS HEARTSTART ADULT MULTIFUNCTION PADS PLUS; ELECTRODE PADS
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PHILIPS MEDICAL SYSTEMS HEARTSTART ADULT MULTIFUNCTION PADS PLUS; ELECTRODE PADS Back to Search Results
Model Number M3713A
Device Problems Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
A follow-up report will be submitted once the investigation is complete.
 
Event Description
It was reported to philips that the m3713a multifunction electrode pads failed to acquire an ecg signal when used on a patient.The failure was observed while the device was in clinical use on a patient.However, no adverse patient impact was reported.
 
Event Description
It was reported to philips that the m3713a multifunction electrode pads failed to acquire an ecg signal when used on a patient.The failure was observed while the device was in clinical use on a patient.However, no adverse patient impact was reported.A different set of pads were used successfully to monitor.
 
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Brand Name
HEARTSTART ADULT MULTIFUNCTION PADS PLUS
Type of Device
ELECTRODE PADS
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
Manufacturer Contact
wendy chadbourne
3000 minuteman road
andover, MA 01810
9786871501
MDR Report Key6188918
MDR Text Key63198739
Report Number1218950-2016-08008
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K002806
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 09/27/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/31/2018
Device Model NumberM3713A
Device Lot Number120115-02
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/14/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received09/27/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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