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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS HEARTSTART PEDIATRIC RADIOTRANSPARENT PADS; MULTI-FUNCTION ELECTRODE PADS
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PHILIPS MEDICAL SYSTEMS HEARTSTART PEDIATRIC RADIOTRANSPARENT PADS; MULTI-FUNCTION ELECTRODE PADS Back to Search Results
Model Number M3719A
Device Problem Detachment Of Device Component (1104)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
It was reported to philips that, during a pediatric resuscitation event, the pediatric defibrillator pads could not adhere to the patient's chest.The gel adhesive came off the pads in strings/clumps.There was no reported negative patient impact.
 
Manufacturer Narrative
(b)(4).A follow up report will be submitted once the investigation is complete.
 
Manufacturer Narrative
(b)(4).The serial number initially reported is for the defibrillator.
 
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Brand Name
HEARTSTART PEDIATRIC RADIOTRANSPARENT PADS
Type of Device
MULTI-FUNCTION ELECTRODE PADS
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman rd.
andover MA 01810 1099
Manufacturer Contact
wendy chadbourne
3000 minuteman rd.
andover, MA 01810-1099
9786597804
MDR Report Key4264536
MDR Text Key5298734
Report Number1218950-2014-06255
Device Sequence Number1
Product Code MLN
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K002806
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,foreign,user facility
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 09/23/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/20/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM3719A
Device Lot Number302515306730
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/06/2014
Is the Reporter a Health Professional? No
Date Manufacturer Received09/23/2014
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Initial
Patient Sequence Number1
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