FDA.reportPublic FDA data

MAUDE MDR 5857528

MDR report key
5857528
Report number
1218950-2016-04828
Event key
0
Event type
3
Date of event
2016-01-18
Date received
2016-08-09
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MRS. WENDY CHADBOURNE
Address
3000 MINUTEMAN ROAD ANDOVER MA 01810 US
Phone
978-978-9786
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1DIGITRAK XT HOLTER RECORDERDIGITRAX XT HOLTER RECORDERPHILIPS MEDICAL SYSTEMSMWJ860322UNKNOWNR Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-08-0901. O

Event Narratives#

N

Patient 1

A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

D

Patient 1

THE CUSTOMER REPORTED RECEIVING A LETTER FROM A PATIENT STATING THAT THEY HAD BEEN BURNED BY A HOLTER RECORDER ELECTRODE. THE PATIENT STATES THEY HAVE BEEN INJURED. AT THIS TIME, THERE IS INSUFFICIENT INFORMATION TO DETERMINE THE CAUSE OF THE FAILURE. THIS COMPLAINT IS BEING MADE REPORTABLE DUE TO THE ALLEGATION OF HARM.

N

Patient 1

THE DEVICE SERIAL NUMBER IS UNKNOWN. DEVICE EVALUATION: PHILIPS PRODUCT SUPPORT TEAM REVIEWED THE COMPLAINT AND THE INFORMATION PROVIDED, INCLUDING PHOTOGRAPHS OF THE REPORTED SKIN REACTION AND OF THE ELECTRODES THAT HAD BEEN IN USE DURING MONITORING. FURTHER INFORMATION WAS REQUESTED FROM THE HOSPITAL. THEY HAVE DECLINED TO PROVIDE ANY ADDITIONAL INFORMATION. UPON REVIEWING THE INFORMATION PROVIDED, NON-PHILIPS SUPPLIES (MEDITRACE ELECTRODES) WERE PICTURED. LACK OF INFORMATION FROM THE HOSPITAL PREVENTED PHILIPS VERIFICATION THAT A HOLTER MONITOR WAS USED ON THIS PATIENT. THE LIMITED AVAILABLE INFORMATION, INCLUDING PHOTOGRAPHS OF THE NON-PHILIPS ELECTRODE USED ON THIS PATIENT, SUPPORTS SUPPLIES WERE USED OUTSIDE THE INTENDED USE DOCUMENTED IN THE PRODUCT IFU. BASED UPON IDENTIFYING THAT NON-PHILIPS LEADS WERE USED, THE BATTERY POWERED RECORDER DOES NOT APPLY ENERGY TO THE PATIENT AND PHILIPS HAS THEREFORE RULED OUT THE RECORDER AS A SOURCE OF THE BURN / SKIN REACTION NOTED IN THE CUSTOMER?S FEEDBACK. THE SKIN REACTION PICTURED WAS THE SIZE AND SHAPE OF THE NON-PHILIPS ELECTRODE THAT WAS PICTURED, BUT ONLY THE SKIN UNDER ONE OF THE ELECTRODES WAS REPORTED TO HAVE HAD A REACTION. THE SKIN PREPARATION BEFORE THE REPORTED MONITORING IS UNKNOWN. PHILIPS CANNOT RULE OUT EITHER THAT THE REPORTED AND PICTURED PATIENT SKIN REACTION WAS DUE TO THE USE OF THE PICTURED NON-PHILIPS ELECTRODES OR THAT IT WAS DUE TO THE SKIN PREPARATION. PHILIPS PROVIDED INFORMATION AND A WRITTEN RESPONSE LETTER. A REVIEW OF THE DEVICE HISTORY RECORD WAS UNABLE TO BE PERFORMED SINCE DEVICE SERIAL NUMBER WAS NOT PROVIDED. A DATA SEARCH PERFORMED ON 28NOVEMBER2017 FOR A PERIOD OF 22 MONTHS FROM 01JAN2016 TO 28NOV2017 FOUND 0 COMPLAINTS WHERE THE USE OF A HOLTER RECORDER WAS ASSOCIATED WITH SECOND DEGREE BURNS OR INJURY. NO TREND EXISTS, NO SYSTEMIC ISSUE FOUND. THE AVAILABLE INFORMATION FROM THIS REPORT DOES NOT SUPPORT THAT THIS FAILURE REPRESENTS A SYSTEMIC, DESIGN, OR LABELING PROBLEM.