MAUDE Adverse Event Report: VYAIRE MEDICAL MEDISORB EF MULTI-ABSORBER, DISPOSABLE; ABSORBENT-CARBON DIOXIDE

Model Number MEDISORB¿ EF MULTI-ABSORBER, DISPOSABLE

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/18/2021

Event Type  malfunction  

Manufacturer Narrative

Vyaire file identification: (b)(4).At this time, the suspect device has not been returned for evaluation.No root cause has been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

Event Description

The customer reported that the medisorb¿ ef multi-absorber, disposable experienced leak issue.The customer attributing anesthetic machine leaks to the medisorb ef canister.The customer confirmed that there was no patient involvement associated with the reported event.

• Brand Name: MEDISORB EF MULTI-ABSORBER, DISPOSABLE
• Type of Device: ABSORBENT-CARBON DIOXIDE
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa IL 60045
• Manufacturer (Section G): MOLECULAR PRODUCTS LTD; parkway harlow business park; harlow, essex, CM19 5FR; UK CM19 5FR
• Manufacturer Contact: erika bonilla ; 510 technology dr,; irvine, CA 92618 ; 7149227837
• MDR Report Key: 11988201
• MDR Text Key: 256046250
• Report Number: 3002807637-2021-00017
• Device Sequence Number: 1
• Product Code: CBL
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MEDISORB¿ EF MULTI-ABSORBER, DISPOSABLE
• Device Catalogue Number: M1173311
• Device Lot Number: (10)5350720
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/18/2021
• Initial Date FDA Received: 06/11/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1