ADU5 ANESTHESIA MACHINE *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-08-07 for ADU5 ANESTHESIA MACHINE * manufactured by Datek Ohmeda.

Event Text Entries

[496407] Datek ohmeda adu5 anesthesia machine / ventillator in use during surgical procedure- medisorb cannister co2 obsorber (ge healthcare) was discovered to be restricting gas flow resulting in high peak inspiratory pressures. All medisorb cannisters from lot # 021056 were pulled from stock and returned to manufacturer. Upon discover the medisorb cannister was changed and problem resolved. No harm to this patient.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1039979
• MDR Report Key: 753796
• Date Received: 2006-08-08
• Date of Report: 2006-08-07
• Date of Event: 2006-07-26
• Date Added to Maude: 2006-08-25
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: ADU5 ANESTHESIA MACHINE
• Generic Name: *
• Product Code: BSZ
• Date Received: 2006-08-07
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: *
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 741612
• Manufacturer: DATEK OHMEDA
• Manufacturer Address: * * *

Device Sequence Number: 2

• Brand Name: MEDISORB CANNISTER CO2 ABSORBER
• Generic Name: *
• Product Code: BSF
• Date Received: 2006-08-07
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: *
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 741617
• Manufacturer: GE HEALTHCARE
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2006-08-08