LAERDAL INFLATE-A-SHEILD 490000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,06,07 report with the FDA on 2002-01-30 for LAERDAL INFLATE-A-SHEILD 490000 manufactured by Laerdal Medical Corp..

Event Text Entries

[241068] This customer received a sample lis (laerdal inflate-a-shield) that was defective and would not inflate. This condition was found during training. The sample was provided to the customer to be evaluated for use in training classes.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2425852-2001-00002
MDR Report Key374634
Report Source00,06,07
Date Received2002-01-30
Date of Report2001-11-07
Report Date2001-11-07
Date Mfgr Received2001-11-14
Device Manufacturer Date2001-05-01
Date Added to Maude2002-02-01
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 Location3
Manufacturer ContactLINDA LORAIN
Manufacturer Street167 MYERS CORNERS ROAD
Manufacturer CityWAPPINGERS FALLS NY 129508840
Manufacturer CountryUS
Manufacturer Postal129508840
Manufacturer Phone8452977770
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameLAERDAL INFLATE-A-SHEILD
Generic NameCPR SHIELD - BARRIER DEVICE
Product CodeCBP
Date Received2002-01-30
Returned To Mfg2001-11-14
Model NumberNA
Catalog Number490000
Lot Number080301
ID Number510K# K001742
OperatorOTHER
Device AvailabilityR
Device Age6 MO
Device Eval'ed by MfgrN
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key363757
ManufacturerLAERDAL MEDICAL CORP.
Manufacturer Address167 MYERS CORNERS RD. WAPPINGERS FALLS NY 125908840 US
Baseline Brand NameLAERDAL INFLATE-A-SHEILD
Baseline Generic NameCPR SHIELD-BARRIER DEVICE
Baseline Model NoNA
Baseline Catalog No490000
Baseline ID510K#K001742


Patients

Patient NumberTreatmentOutcomeDate
10 2002-01-30

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