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

Model Number MR290V

Device Problem Crack (1135)

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

Event Type  malfunction  

Event Description

A healthcare facility in ireland reported via a fisher and paykel healthcare (f&p) field representativeon that three mr290v vented autofeed humidification chambers were found cracked.There was no patient involvement.

Manufacturer Narrative

(b)(4).The complaint mr290v vented autofeed humidification chambers are currently en route to fisher & paykel healthcare (f&p) for evaluation.We will provide a follow up report upon completion of investigation.

Manufacturer Narrative

(b)(4).Method: only one of the subject (b)(6) vented autofeed humidification chambers was returned to fisher & paykel healthcare (f&p) in new zealand where it was visually inspected and analysed.Results: visual inspection of the returned (b)(6) chamber confirmed two long vertical crack lines propagating toward the base of the chamber.Stress marks were identified around bottom of inlet port and around the dome.A leak test was performed on the subject (b)(6) chamber, the results indicated that the leak rate was not within the specified range.The manufacturing records were reviewed for this lot.The devices in this manufacturing lot passed all the required quality control measures, confirming they were manufactured in accordance with specification.Additionally, no non-conformances were noted during the manufacturing process of these lots.Conclusion: we are unable to determine the cause of the reported event.However, our investigation indicates that the most likely cause is impact damage.The (b)(6) chambers are designed and tested to conform to iso 5367 breathing tubes intended for use with anaesthetic apparatus and ventilators.Every (b)(6) chamber is pressure tested following the manufacturing process to check for any leaks present in the chamber dome 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.Our user instructions that accompany the (b)(6) 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 (b)(6) above the maximum operating pressure may lead to cracking, water leakage and, on rare occasions, could lead to a loss of ventilation pressure." - "do not use the chamber if the seals are not intact when received, or if it has been dropped.".

Event Description

A healthcare facility in ireland reported via a fisher and paykel healthcare (f&p) field representative that three (b)(6) vented autofeed humidification chambers failed the ventilator leak test and were subsequently found to have cracks on the side of the chamber.There was no patient involvement.

• Brand Name: VENTED AUTOFEED HUMIDIFICATION CHAMBER
• Type of Device: AUTOFEED CHAMBER
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer Contact: omid taheri ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 8007923912
• MDR Report Key: 17657826
• MDR Text Key: 322402547
• Report Number: 9611451-2023-00810
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K934140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 08/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 220708
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/29/2023
• Initial Date FDA Received: 08/30/2023
• Supplement Dates Manufacturer Received: 09/25/2023
• Supplement Dates FDA Received: 10/02/2023
• 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
• Treatment: F&P RT266 INFANT EVAQUA2 BREATHING CIRCUIT.; F&P RT266 INFANT EVAQUA2 BREATHING CIRCUIT.