MAUDE Adverse Event Report: VYAIRE MEDICAL INC. HME NONFILTERED BYPASS 25/CS; HUMIDIFICATION AND FILTERING

Model Number HME NONFILTERED BYPASS 25/CS

Device Problem Mechanical Problem (1384)

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

Event Date 08/02/2021

Event Type  malfunction  

Manufacturer Narrative

Vyaire file identification: (b)(4).At this time, the suspect device has not been returned for evaluation.No root cause has been determined yet.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 hme nonfiltered bypass 25/cs experienced inner filter portion deteriorated.As of this time, there is no information regarding patient involvement associated with this reported event.

• Brand Name: HME NONFILTERED BYPASS 25/CS
• Type of Device: HUMIDIFICATION AND FILTERING
• Manufacturer (Section D): VYAIRE MEDICAL INC.; 26125 n. riverwoods blvd.; mettawa IL 60045
• Manufacturer (Section G): AMSINO MEDICAL (SHANGHAI) CO.; building no. 1-3, lane 355; huazhe road songjiang export; 20161 ; CH 20161
• Manufacturer Contact: erika bonilla ; 510 technology dr; irvine, IL 92618 ; 7149227837
• MDR Report Key: 12385752
• MDR Text Key: 268757266
• Report Number: 3005515211-2021-00006
• Device Sequence Number: 1
• Product Code: BYD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HME NONFILTERED BYPASS 25/CS
• Device Catalogue Number: 003020
• Device Lot Number: SJ0820031
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/02/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1