MAUDE Adverse Event Report: VYAIRE MEDICAL MEDISORB EF MULTI-ABSORBER, DISPOSABLE; CO2 ABSORBERS

Model Number MEDISORB¿ EF MULTI-ABSORBER, DISPOSABLE

Device Problem Moisture or Humidity Problem (2986)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

As of now, samples have not been returned for evaluation.There are four(4) lot numbers affected: 7961019, 4990819, 5120819 and 8291019.Any additional information received from the customer will be included in a follow-up report.

Event Description

The customer reported that the m1173311 medisorb ef multi-absorber, disposable granules in cannisters are not allowing water/moisture to descend down into the canister.No harm reported to the patient.

• Brand Name: MEDISORB EF MULTI-ABSORBER, DISPOSABLE
• Type of Device: CO2 ABSORBERS
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa, il
• Manufacturer (Section G): MOLECULAR PRODUCTS LTD; parkway harlow business; park harlow essex, uk cm19 5fr; harlow, essex, CM19 5FR; UK CM19 5FR
• Manufacturer Contact: mindy faber ; 26125 n. riverwoods blvd.; mettawa, il ; 7570116
• MDR Report Key: 9849713
• MDR Text Key: 192649749
• Report Number: 3002807637-2020-00002
• 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: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2020
• 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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1