MAUDE Adverse Event Report: VYAIRE MEDICAL MEDISORB¿ EX, DISPOSABLE; ABSORBENT, CARBON-DIOXIDE

Catalog Number 2079796-001

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/29/2019

Event Type  Injury  

Manufacturer Narrative

Vyaire has received photos of the sample for the investigation.Once the investigation is complete or if we receive any additional information we will provide a follow up emdr.

Event Description

A customer contacted vyaire medical to report a cracked sodalime canister that had a leak in the circuit noted during use on a patient.Customer explained that soda lime was attached to the machine, but as soon as the machine tried to ventilate the patient, the bellows would not fill.This resulted in failure to ventilate the patient appropriately but was quickly rectified.Patient was hand ventilated.No harm came to the patient.

Manufacturer Narrative

H10 comment: the sample photo was analyzed and no failure was detected.A device history record (dhr) of the lot number revealed no issues.A root cause could not be determined.

• Brand Name: MEDISORB¿ EX, DISPOSABLE
• Type of Device: ABSORBENT, CARBON-DIOXIDE
• Manufacturer (Section D): VYAIRE MEDICAL; 22745 savi ranch pkwy; yorba linda 92887
• MDR Report Key: 8928173
• MDR Text Key: 155499781
• Report Number: 3002807637-2019-00001
• Device Sequence Number: 1
• Product Code: CBL
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/29/2019

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2079796-001
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/29/2019
• Initial Date FDA Received: 08/23/2019
• Supplement Dates Manufacturer Received: 11/11/2019
• Supplement Dates FDA Received: 12/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention