MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LIMITED VENTED AUTOFEED HUMIDIFICATION CHAMBER; AUTOFEED CHAMBER

Model Number MR290V

Device Problems Crack (1135); Device Damaged Prior to Use (2284); Dent in Material (2526)

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

Event Date 06/29/2022

Event Type  malfunction  

Event Description

A distributor reported on behalf of a healthcare facility in south africa that six mr290v vented autofeed humidification chambers were found cracked and dented before use.There was no patient involvement.

Manufacturer Narrative

(b)(4).Device 1, 2 & 3: batch: 2102074441, date of manufacture: 09 mar 2022, udi: (b)(4).Device 4: batch: 2101980011, date of manufacture: 13 jan 2022, udi: (b)(4).Device 5: batch: 2101932194, date of manufacture: 02 dec 2021 , udi: (b)(4).Device 6: batch: not provided, date of manufacture: not provided, udi: not provided.The complaint mr290v vented autofeed humdification chambera are currently en-route to fisher & paykel healthcare for evaluation.We will provide a follow up report upon completion of our investigation.

Manufacturer Narrative

Ps(b)(4).Section d4 and h4: device 1, 2 & 3: batch: 2102074441, date of manufacture: 09 mar 2022, udi: (b)(4).Device 4: batch: 2101980011, date of manufacture: 13 jan 2022, udi: (b)(4).Device 5: batch: 2101932194, date of manufacture: 02 dec 2021, udi: ((b)(4).Device 6: batch: not provided, date of manufacture: not provided, udi: not provided.Corrected data: section d9 device available for evaluation? no.Section h3 device evaluated by manufacturer? other.Method: the complaint mr290v vented autofeed humidification chambers were not returned to fisher & paykel healthcare for evaluation.Our investigation is thus based on the information and photographs provided by the customer and our knowledge of the product.Results: visual inspection of the provided photographs revealed that the chamber bases were deformed and chamber domes were cracked.Conclusion: without the complaint device, we are unable to determine the cause of the reported event.However, the provided photographs indicate that the damage were most likely due to transport damage.Every mr290v chamber is pressure tested following the manufacturing process to check for any leaks present in the chamber due to cracks and other causes.Any chamber which fails this test is rejected.In addition, the pressure test is followed by a visual inspection of each chamber.No cracks in the chamber dome are acceptable.Any chamber that fails this inspection is rejected.The subject mr290v chambers would have met the required specification at the time of production.Our user instructions that accompany the mr290v vented autofeed humidification chamber state the following: - "do not soak, wash, sterilize, or reuse this product.Avoid contact with chemicals, cleaning agents, or hand sanitizers." - "ensure appropriate ventilator or flow source alarms are set before connecting breathing set to patient." - "perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient." - "use of the mr290 above the maximum operating pressure may lead to cracking, water leakage and, on rare occasions could lead to a loss of ventilation pressure.".

Event Description

A distributor reported on behalf of a healthcare facility in south africa that six mr290v vented autofeed humidification chambers were found cracked and dented before use.There was no patient involvement.

• Brand Name: VENTED AUTOFEED HUMIDIFICATION CHAMBER
• Type of Device: AUTOFEED CHAMBER
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer Contact: faranak gomarooni ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494534000
• MDR Report Key: 14902307
• MDR Text Key: 296778127
• Report Number: 9611451-2022-00595
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K934140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MR290V
• Device Catalogue Number: MR290V
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: F&P RT224 INFANT CONTINUOUS FLOW BREATHING CIRCUIT; F&P RT224 INFANT CONTINUOUS FLOW BREATHING CIRCUIT