WALKAWAY96 N/A B1018-284

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2015-04-13 for WALKAWAY96 N/A B1018-284 manufactured by Beckman Coulter.

Event Text Entries

[15242876] It was reported that when attempting to close the panel access door of the walkaway instrument, the spring from the panel access door hinge was ejected and landed on the counter. The operator was wearing eye protection at the time and there were no reported injury due to this event.
Patient Sequence No: 1, Text Type: D, B5


[15744566] The field service engineer (fse) repaired the access door hinge component and verified that the service hatch door was fully functional. A field action msi 14-01 (fda z-1990-2014) was issued on june 2014 for this type of failure. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2919016-2015-00010
MDR Report Key4685291
Report Source05,06
Date Received2015-04-13
Date of Report2015-03-20
Date of Event2015-03-20
Date Mfgr Received2015-03-20
Device Manufacturer Date2012-09-27
Date Added to Maude2015-05-13
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 ContactNORMA RAHILL
Manufacturer Street1584 ENTERPRISE BLVD
Manufacturer CityWEST SACRAMENTO CA 95691
Manufacturer CountryUS
Manufacturer Postal95691
Manufacturer Phone9163742139
Manufacturer G1BECKMAN COULTER
Manufacturer Street2040 ENTERPRISE BLVD
Manufacturer CityWEST SACRAMENTO CA 95691
Manufacturer CountryUS
Manufacturer Postal Code95691
Single Use3
Remedial ActionRC
Previous Use Code3
Removal Correction NumberZ-1990-2014
Event Type3
Type of Report3

Device Details

Brand NameWALKAWAY96
Generic NameINSTRUMENT FOR AUTO READER & INTERPRETATION OF OVERNIGHT SUSCEPT. SYSTEMS
Product CodeLRG
Date Received2015-04-13
Model NumberN/A
Catalog NumberB1018-284
Lot NumberN/A
OperatorOTHER HEALTH CARE PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBECKMAN COULTER
Manufacturer AddressWEST SACRAMENTO CA 95691 US 95691


Patients

Patient NumberTreatmentOutcomeDate
10 2015-04-13

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