METRO LIFELINE LEC 9150 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-09-29 for METRO LIFELINE LEC 9150 * manufactured by *.

Event Text Entries

[18445533] In 2003, representative to clinic called co to order a replacement backboard. Questioning by co's customer service representative revealed that the board reportedly cracked during reanimation of the patient with heart pressure massage. The board was replaced and patient was successfully resuscitated. There are no known adverse results for the reported event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1530344-2003-00001
MDR Report Key487178
Date Received2003-09-29
Date of Report2003-09-17
Date of Event2003-08-25
Date Mfgr Received2003-09-08
Date Added to Maude2003-10-07
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
Manufacturer ContactDAVID REPPERT
Manufacturer Street651 N. WASHINGTON ST.
Manufacturer CityWILKES-BARRE PA 18705
Manufacturer CountryUS
Manufacturer Postal18705
Manufacturer Phone5707063114
Manufacturer G1INTERMETRO INDUSTRIES CORP
Manufacturer Street1150 STATE STREET
Manufacturer CityFOSTORIA OH 44830
Manufacturer CountryUS
Manufacturer Postal Code44830
Single Use3
Remedial ActionOT
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMETRO LIFELINE
Generic NameBOARD, CARDIOPULMONARY
Product CodeFOA
Date Received2003-09-29
Returned To Mfg2003-09-08
Model NumberLEC 9150
Catalog Number*
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key476067
Manufacturer*
Manufacturer Address* * *
Baseline Brand NameMETRO LIFELINE
Baseline Generic NameBOARD, CARDIOPULMONARY
Baseline Model NoLEC 9150
Baseline Catalog NoNA
Baseline IDNA
Baseline Device FamilyNA
Baseline Shelf Life Contained*
Baseline Shelf Life [Months]*
Baseline PMA FlagN
Baseline 510K PMNN
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptY


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2003-09-29

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.