MAUDE Adverse Event Report: VYAIRE MEDICAL AIRLIFE¿HMEF 750/S, DISPOSABLE; FILTER, BACTERIAL, BREATHING-CIRCUIT

Catalog Number M1004132

Device Problem No Flow (2991)

Patient Problems Cyanosis (1798); Low Oxygen Saturation (2477)

Event Date 08/02/2019

Event Type  Injury  

Manufacturer Narrative

Vyaire complaint number: (b)(4).Any additional information provided by the customer will be addressed in a follow up report.Vyaire has received the sample from the customer; however an evaluation is not completed yet.Once evaluation is completed, vyaire will provided a follow up emdr.

Event Description

Customer reported to vyaire medical that after about 15 hours, a patient developed cyanosis with an unknown amount of decrease in spo2 while using the product due an occlusion of the artificial nose filter.The patient's condition improved after switching to another artificial nose filter.The event occurred on the first day of use.There was no information about the equipment which was used with this product.The product was used for the first time for this patient, and the patient may had excessive secretion.Patient hospitalization was not extended due to this issue, or additional treatment was not indicated.

Manufacturer Narrative

H10 comment: the sample was fully evaluated but no failure was detected.The reported issue could not be duplicated, so no root cause was could be determined.

• Brand Name: AIRLIFE¿HMEF 750/S, DISPOSABLE
• Type of Device: FILTER, BACTERIAL, BREATHING-CIRCUIT
• Manufacturer (Section D): VYAIRE MEDICAL; 22745 savi ranch pkwy; yorba linda CA 92887
• MDR Report Key: 8956452
• MDR Text Key: 156567408
• Report Number: 3004050971-2019-00002
• Device Sequence Number: 1
• Product Code: CAH
• Combination Product (y/n): N
• PMA/PMN Number: K031653
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/05/2019

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 Catalogue Number: M1004132
• Initial Date Manufacturer Received: 08/05/2019
• Initial Date FDA Received: 09/03/2019
• Supplement Dates Manufacturer Received: 09/26/2019
• Supplement Dates FDA Received: 11/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other