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

Model Number	MEDISORB, MULTI ABSORBER ORIGINAL
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to vyaire medical that the co2 is not reading accurately even though the agent was correct.The medisorb, multi absorber original looked old and yellowed with an expiration date of 2019.It was replaced with no change.No patient consequence was reported.
Additional Manufacturer Narrative
At this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: MEDISORB, MULTI ABSORBER ORIGINAL
• Common Device Name: ABSORBENT, CARBON-DIOXIDE
• Manufacturer (Section D): VYAIRE MEDICAL OY; kuortaneenkatu 2; helsinki etela-suomen laani; helsinki, 510 ; FI 510
• 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: 15592285
• Report Number: 3010838917-2022-00016
• Device Sequence Number: 14003405
• Product Code: CBK
• UDI-Device Identifier: 10190752184329
• UDI-Public: (01)10190752184329
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/14/2022

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
• Operator of Device: Health Professional
• Device Model Number: MEDISORB, MULTI ABSORBER ORIGINAL
• Device Catalogue Number: M1173310
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2022
• Initial Report FDA Received Date: 10/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown