ECG EVENT RECORDER CCST80X4

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07,08 report with the FDA on 2012-07-09 for ECG EVENT RECORDER CCST80X4 manufactured by Spacelabs Healthcare Ltd..

Event Text Entries

[2873489] Spacelabs received a report that a cardiocall ecg event recorder was hot and melted the plastic enclosure close to the battery. A patient stated that he was burned.
Patient Sequence No: 1, Text Type: D, B5


[10066748] Spacelabs is filing this report because we were advised a patient injury involved in this complaint on (b)(6) 2012. The initial complaint received on (b)(4) 2011 did not identify any patient involvement therefore no mdr was filed. The subject device was returned to spacelabs facility for investigation. The root cause was identified as battery short, which was caused by an improperly trimmed wire on the negative contact piercing insulation on the battery and shorting to the positive side of battery. Spacelabs requires wires be trimmed flush after soldering in the assembly procedures. Spacelabs has updated the assembly process work instruction by adding photos to clearly indicate correct trimming of wire after soldering to battery contact. Retraining of this process was conducted to prevent any future reoccurrences. The customer's unit has been replaced. A review of available data did not identify any similar complaints. We consider this malfunction to be an isolated case. We have concluded that no further action is required and consider this issue closed.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3023361-2012-00032
MDR Report Key2646385
Report Source01,07,08
Date Received2012-07-09
Date of Report2012-07-09
Date of Event2011-09-28
Date Mfgr Received2012-06-22
Device Manufacturer Date2010-10-12
Date Added to Maude2012-10-24
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationBIOMEDICAL ENGINEER
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactMS. MIAOMIAO ZHENG
Manufacturer Street5150 220TH AVE SE
Manufacturer CityISSAQUAH WA 98029
Manufacturer CountryUS
Manufacturer Postal98029
Manufacturer Phone4256577200
Manufacturer G1SPACELABS MEDICAL INC.
Manufacturer Street5150 220TH AVE SE
Manufacturer CityISSAQUAH WA 98029
Manufacturer CountryUS
Manufacturer Postal Code98029
Single Use3
Remedial ActionRL
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameECG EVENT RECORDER
Generic NameCARDIOCALL
Product CodeDXH
Date Received2012-07-09
Returned To Mfg2011-10-14
Model NumberCCST80X4
Device Expiration Date2011-10-13
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSPACELABS HEALTHCARE LTD.
Manufacturer Address1 HARFORDE COURT JOHN TATE ROAD HERTFORD, SG137NW UK SG13 7NW


Patients

Patient NumberTreatmentOutcomeDate
10 2012-07-09

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