DRAGERSORB *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-10-26 for DRAGERSORB * manufactured by Drager Medical Ag And Co. Kgaa.

Event Text Entries

[743840] During a routine procedure (using general anesthetic) with the patient breathing spontaneously through an lma (laryngeal mask airway), the anesthesia machine alarmed: low fresh gas flow, negative pressure while in the pressure support mode. Return to spontaneous mode caused the alarm to stop. After the procedure it was found that the soda lime canister had created a small negative pressure leak which started the alarm. Soda lime particles were noted to be escaping the sealed portion of the canister and getting into the breathing circuit and into the machine. The seal inside the canister was inserted sideways within the canister, allowing the soda lime particles out of the sealed portion. The machine had passed all safety/leak checks that morning.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number935449
MDR Report Key935449
Date Received2007-10-26
Date of Report2007-10-26
Date of Event2007-10-19
Report Date2007-10-26
Date Reported to FDA2007-10-26
Date Added to Maude2007-11-01
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Sequence Number: 1

Brand NameDRAGERSORB
Generic NameSODA LIME CANISTER
Product CodeCBL
Date Received2007-10-26
Model Number*
Catalog Number*
Lot NumberARXN-F002
ID Number*
Device AvailabilityY
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key907495
ManufacturerDRAGER MEDICAL AG AND CO. KGAA
Manufacturer AddressMOISLINGER ALLEE 53-55 D-23542 LUBECK US

Device Sequence Number: 2

Brand NameFABIUS GS
Generic NameANESTHESIA MACHINE
Product CodeBSZ
Date Received2007-10-26
Model Number*
Catalog Number*
Lot Number*
ID Number*
Device AvailabilityY
Implant FlagN
Date Removed*
Device Sequence No2
Device Event Key907496
ManufacturerDRAGER MEDICAL AG AND CO. KGAA
Manufacturer AddressMOISLINGER ALLEE 53-55 D-23542 LUBECK US

Device Sequence Number: 3

Brand NameVITAL SIGNS
Generic NameBREATHING CIRCUIT
Product CodeBZO
Date Received2007-10-26
Model Number*
Catalog Number*
Lot Number*
ID Number*
Device AvailabilityN
Implant FlagN
Date Removed*
Device Sequence No3
Device Event Key907497
ManufacturerVITAL SIGNS, INC.
Manufacturer Address20 CAMPUS ROAD TOTOWA NJ 07512 US

Patients

Patient NumberTreatmentOutcomeDate
10 2007-10-26
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