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

Model Number MEDISORB¿ MULTI-ABSORBER ORIGINAL, DISPOSABLE

Device Problem Mechanical Problem (1384)

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

Event Date 12/23/2020

Event Type  Injury  

Manufacturer Narrative

At this time, the suspect device has not been returned for evaluation.Therefore, no root cause could be determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

Event Description

It was reported to vyaire medical that there is a leak on medisorb¿ multi-absorber original, disposable.This issue was detected during clinical use and they have provided manual ventilation to the patient until transfer to another anesthesia machine.The customer confirmed that there was no patient harm associated with the reported event.

Manufacturer Narrative

Additional information; no sample is available for return.(iincomplete).

• Brand Name: MEDISORB MULTI-ABSORBER ORIGINAL, DISPOSABLE
• Type of Device: ABSORBENT, CARBON-DIOXIDE
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa IL 60045
• MDR Report Key: 11485380
• MDR Text Key: 239798073
• Report Number: 3002807637-2021-00009
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 02/17/2021

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 Model Number: MEDISORB¿ MULTI-ABSORBER ORIGINAL, DISPOSABLE
• Device Catalogue Number: M1173310
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/17/2021
• Initial Date FDA Received: 03/15/2021
• Supplement Dates Manufacturer Received: 05/31/2021
• Supplement Dates FDA Received: 06/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention