FDA.reportPublic FDA data

MAUDE MDR 9908271

MDR report key
9908271
Report number
2112020-2020-00236
Event key
0
Event type
3
Date of event
2020-02-14
Date received
2020-03-31
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#

Address
269 MILL ROAD CHELMSFORD MA 01824 US
Phone
978-978-9784
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1G3 PLUS AUTO, AED,GERMAN, PKGAUTOMATED EXTERNAL DEFIBRILLATORCARDIAC SCIENCE CORPORATIONMKJ9390A-5089390A-508NAR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-310

Event Narratives#

N

Patient 1

ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE DEVICE FOR EVALUATION AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.

D

Patient 1

COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A FEMALE PATIENT (AGE UNKNOWN), THE DEVICE SELF DISCHARGED. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.