MAUDE Adverse Event Report: VC/FDA CONSULTING AMSORB PLUS; ABSORBENT, CARBON-DIOXIDE

Model Number AMAB3801

Device Problems Component or Accessory Incompatibility (2897); Gas/Air Leak (2946)

Patient Problem No Patient Involvement (2645)

Event Date 03/11/2020

Event Type  malfunction  

Event Description

During room turnover anesthesia gas machine did not pass leak test.After in-servicing bio-med was called.It was noted by bio-med rep that the engineering on the amsorb plus product is off by 1mm on the ge machine which was causing a small leak to be detected.After researching we noted that some machines will pick up the leak and some will not due to the minute offsetting.Our concern was if this was transpiring in other facilities but has not been reported due to it being caught before patient is attached to machine or anesthesia tech not realizing it is an engineering malfunction.

• Brand Name: AMSORB PLUS
• Type of Device: ABSORBENT, CARBON-DIOXIDE
• Manufacturer (Section D): VC/FDA CONSULTING; 7549 spring lake dr. no. c-2; bethesda MD 20817
• MDR Report Key: 9902766
• MDR Text Key: 185711625
• Report Number: 9902766
• Device Sequence Number: 1
• Product Code: CBL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: AMAB3801
• Device Catalogue Number: AMAB3801
• Device Lot Number: 210619F31
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/19/2020
• Event Location: Hospital
• Date Report to Manufacturer: 03/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1