MARTELL PRINTER RECHARGEABLE BATTERY 06F21-35

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-12-07 for MARTELL PRINTER RECHARGEABLE BATTERY 06F21-35 manufactured by Martell Instruments.

Event Text Entries

[1277713] On (b)(6)2009, abbott point of care was contacted by a customer who reported a martell printer rechargeable battery for the i-stat1 analyzer was hot to touch. There was no report of any injury associated with the complaint.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2245578-2009-00048
MDR Report Key1570554
Report Source05
Date Received2009-12-07
Date of Report2009-12-03
Date of Event2009-11-05
Date Mfgr Received2009-11-05
Date Added to Maude2010-07-30
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactPETER SCOTT
Manufacturer Street400 COLLEGE RD
Manufacturer CityPRINCETON NJ 08540
Manufacturer CountryUS
Manufacturer Postal08540
Manufacturer G1MARTELL INSTRUMENTS
Manufacturer CityDURHAM
Manufacturer CountryUK
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMARTELL PRINTER RECHARGEABLE BATTERY
Generic NameMARTELL RECHARGEABLE BATTERY
Product CodeFCO
Date Received2009-12-07
Model NumberNA
Catalog Number06F21-35
Lot NumberNA
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerMARTELL INSTRUMENTS
Manufacturer AddressDURHAM UK


Patients

Patient NumberTreatmentOutcomeDate
10 2009-12-07

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