MAUDE Adverse Event Report: ARMSTRONG MEDICAL LTD. AMSORB; ABSORBENT, CARBON-DIOXIDE

Model Number AMAB4001

Device Problems Crack (1135); Leak/Splash (1354); Loose or Intermittent Connection (1371)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/07/2015

Event Type  malfunction  

Event Description

Complete system leak - unable to ventilate patient.Noticed co2 absorber loose and changed the canister.The co2 absorbent on "trial" was cracked or broken on top.This caused a leak in the anesthesia machine and we were unable to ventilate the patient.Able to ventilate after changing the canister.

• Brand Name: AMSORB
• Type of Device: ABSORBENT, CARBON-DIOXIDE
• Manufacturer (Section D): ARMSTRONG MEDICAL LTD.; 7549 spring lake dr., no. c-2; bethesda MD 20817
• MDR Report Key: 5027399
• MDR Text Key: 23947905
• Report Number: 5027399
• Device Sequence Number: 1
• Product Code: CBL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Report Date: 07/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 01/31/2018
• Device Model Number: AMAB4001
• Device Lot Number: 090215F41
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/14/2015
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 07/14/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/25/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 77 YR