MAUDE Adverse Event Report: VYAIRE MEDICAL AIRLIFE¿ BUBBLE HUMIDIFIER WITH 6 PSI PRESSURE RELIEF VALVE; HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)

Model Number HUMIDIFIER EMPTY 6 PSI BLUE CAP 50/CS

Device Problem Defective Component (2292)

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

Event Date 10/12/2023

Event Type  Injury  

Event Description

It was reported to vyaire medical that prior to extubation, the respiratory therapist (rt) was setting up oxygen to match what was on the vent.Shortly after, a loud whistle was heard from the safety pressure valve.Rt checked equipment and noted there was no hole on 002006 - humidifier empty 6 psi blue cap 50/cs leading to the cannula to deliver oxygen.When rt grabbed a new one from the respiratory closet, he noted it had the same defect.The customer confirmed that there was no patient harm/injury associated with the event.

Manufacturer Narrative

H3: 81 other - 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.

Manufacturer Narrative

Results of the investigation: the device history record of the lot number 0004208007 reported on the complaint of the fg part number 002006 with udi code (01)10190752114791(10)0004208007(11)220202 was reviewed in order to detect any issue related to the reported defect during its manufacturing, and no issues were found.Based on the investigation and since the customer sent 11 closed physical samples of fg part number 002006 with lot number 0004239910 for the investigation, an inspection was conducted by quality personnel from the assembly area in accordance with pqas 001900 etal.The inspection included a valve relief test and straw test, with all 11 samples deemed acceptable.Furthermore, quality personnel from the receiving area inspected the samples in accordance with rmqas 3128a etal, conducting an occlusion test.The findings revealed that all 11 samples were occluded, confirming the reported defect.Material might have contributed to the reported defect since component cap humidifier part number 65-4193b was found to be occluded in all 11 samples.Part number 65-4193b is not manufactured by us.Although incoming inspection personnel are trained on rmqas 3128a etal to perform an inspection looking for incorrect information, color, contamination, flash, cracks, bubbles, the wrong material, and a dimensional test, additionally, a sampling to detect occlusion on the cap currently used for fg 002006, part number 65-4193c, within the inventory was conducted.The results did indicate occlusion in the sampled caps.Therefore, the root cause was determined.In addition, pfmea-44a-011 was reviewed, and controls were implemented for this type of defect.

• Brand Name: AIRLIFE¿ BUBBLE HUMIDIFIER WITH 6 PSI PRESSURE RELIEF VALVE
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 north riverwoods blvd; mettawa IL 60045
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.; cerrada vía de la producción; parque undustrial mexicali iii; mexicali 21397 ; MX 21397
• Manufacturer Contact: sandra valencia ; 510 technology drive; irvine, CA 92618 ; 2402760001
• MDR Report Key: 18212236
• MDR Text Key: 329043311
• Report Number: 8030673-2023-00360
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 10885403006432
• UDI-Public: (01)10885403006432(10)0004208007
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K991484
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HUMIDIFIER EMPTY 6 PSI BLUE CAP 50/CS
• Device Catalogue Number: 002006
• Device Lot Number: 0004208007
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention