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 02/22/2022

Event Type  Injury  

Manufacturer Narrative

There is no photo, sample nor lot number; therefore a definitive root cause could not be determined and corrective or preventive action is not indicated at this time.This complaint will be included in the ongoing complaint trending analysis.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 m1173311 medisorb¿ ef multi-absorber, disposable leaked air during use and had to be replaced.There was no patient harm reported.

• Brand Name: MEDISORB¿ EF MULTI-ABSORBER, DISPOSABLE
• Type of Device: ABSORBENT, CARBON-DIOXIDE
• Manufacturer (Section D): VYAIRE MEDICAL; 510 technology dr; irvine IL 92618
• 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, IL 92618 ; 7149227837
• MDR Report Key: 13993436
• MDR Text Key: 288470240
• Report Number: 3002807637-2022-00028
• Device Sequence Number: 1
• Product Code: CBL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2022
• Is this an Adverse Event Report?: Yes
• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/07/2022
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention