GE MULTI ABSORBER, DISPOSABLE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-08-14 for GE MULTI ABSORBER, DISPOSABLE manufactured by Ge.

Event Text Entries

[19960349] Item: ge - general electric-multi absorber, disposable. We have had approx 5 of these co2 absorber units arrive with cracks in the plastic, which have caused leakage of anesthetic/o2 gases from the anesthesia machine, in some cases, severe enough to prevent adequate ventilation of the pt. This device is the co2 absorber for use with the ge healthcare s/5 avance anesthesia machine. Although no pts have been harmed as a result of this, the potential for pt harm exists. The cause of the cracks are not known , however, i suspect they occur during the shipping process. Since the plastic case is somewhat thin and flimsy, i suspect that a better protective case may be needed for shipping 6 to the case. The cracks have occurred in different parts of the absorber, and do not appear to be the direct result of a manufacturing defect or design defect. A warning message on the cannister to examine carefully for cracks and test with positive pressure prior to use may be helpful.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5003483
• MDR Report Key: 899935
• Date Received: 2007-08-14
• Date of Report: 2007-08-14
• Date of Event: 2007-08-14
• Date Added to Maude: 2007-09-05
• 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
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: GE MULTI ABSORBER, DISPOSABLE
• Generic Name: CO2 ABSORBER
• Product Code: BSF
• Date Received: 2007-08-14
• ID Number: REF 8003138
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Date Removed: B
• Device Sequence No: 1
• Device Event Key: 880782
• Manufacturer: GE
• Manufacturer Address: GREAT BRITAIN

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Deathisabilit	2007-08-14