AMSCO 430 FL-XXXX

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 1997-09-19 for AMSCO 430 FL-XXXX manufactured by Hoplab Inc..

Event Text Entries

[70402] A-reported info faulty thermostat caused sump water to overheat and evaporate. The steam escaped the chamber when the access door was opened and the operator was slightly burned to the back of the right hand (not a serious injury). B-reportable malfunction steam caused by sump water evaporation will escape from washer and might cause severe burns if all of the following conditions are met simultaneously: thermostat failure with contactor closed during the thermal rinse phase; operator not following safety warning and opens chamber door before cycle completion; operator not wearing recommended protective equipment (glove and face shield) as per labeling of washer.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9680353-1997-00001
MDR Report Key122060
Report Source07
Date Received1997-09-19
Date of Report1997-07-28
Date of Event1997-07-05
Date Mfgr Received1997-07-08
Device Manufacturer Date1989-12-01
Date Added to Maude1997-09-26
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Single Use3
Remedial ActionRL
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameAMSCO
Generic NameRELIANCE SERIES WASHER
Product CodeECG
Date Received1997-09-19
Model Number430
Catalog NumberFL-XXXX
Lot NumberNA
ID NumberNA
OperatorOTHER
Device AvailabilityY
Device Eval'ed by MfgrY
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key119552
ManufacturerHOPLAB INC.
Manufacturer Address415 RUE ALEGANIS BEAUPORT, QUEBEC CA GIC 4N4
Baseline Brand NameAMSCO
Baseline Generic NameRELIANCE SERIES WASHER
Baseline Model No430
Baseline Catalog NoFL-XXXX
Baseline IDNA
Baseline Device FamilyNA
Baseline Shelf Life [Months]NA
Baseline PMA FlagN
Baseline 510K PMNY
Premarket NotificationK921996
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
10 1997-09-19

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