AMSORB *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-09-02 for AMSORB * manufactured by Armstrong Med.

Event Text Entries

[16106937] The amsorb product is an absorbent used in or anesthesia machines. The anesthesia staff has noted an increase in co2 retention with their surgical pts. Prior to use of amsorb this was not an issue. When the amsorb absorbent is changed the co2 retention is resolved. The mfr states the material needs to be changed every 4 days, we are having to change the product close to daily to prevent co2 retention.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1036522
• MDR Report Key: 746601
• Date Received: 2005-09-02
• Date of Report: 2005-09-02
• Date of Event: 2005-07-28
• Date Added to Maude: 2006-08-14
• 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: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: AMSORB
• Generic Name: ABSORBENT MATERIAL USED IN ANESTHESIA MACHINES
• Product Code: CBL
• Date Received: 2005-09-02
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 734397
• Manufacturer: ARMSTRONG MED
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2005-09-02