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

Model Number MR20V

Device Problem Crack (1135)

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

Event Date 01/08/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4) section d4 & h4: device 1-2: lot#: 2102698415 ; date of manufacturing; 19 july 2023; udi: (b)(4) device 3: lot#: 2102667465; date of manufacturing; 26 june 2023; udi: (b)(4) section h10: the subject (b)(6) autofeed humidification chambers have been requested to be returned to f&p healthcare new zealand for evaluation.We will provide a follow up report upon completion of our investigation.

Event Description

A distributor reported on behalf of a healthcare facility in china, via a fisher & paykel (f&p) healthcare representative, that three (b)(6) vented autofeed humidification chambers provided with rt265 infant dual-heated evaqua2 breathing circuits were found leaking water prior to patient use.There was no patient involvement.

Manufacturer Narrative

Ps440024 corrections: section d: updated d1, d2, d4 to state mr290v vented autofeed humidification chamber as the suspect medical device.Section g: updated 510(k) to k934140 section d4 & h4: device 1-2: lot#: 2102698415 ; date of manufacturing; 19 july 2023; udi: (01)09420012430205(10)2102698415(11)230719 device 3: lot#: 2102667465; date of manufacturing; 26 june 2023; udi: (01)09420012430205(10)2102667465(11)230626 section h11: method: the subject mr290v vented autofeed humidification chambers were not returned to fisher & paykel healthcare for evaluation, therefore, no investigation could be performed.Conclusion: without the subject devices, we are unable to determine what may have caused the reported leakage.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 mr290 chamber 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 china, via a fisher & paykel (f&p) healthcare representative, that three mr290v vented autofeed humidification chambers provided with rt265 infant dual-heated evaqua2 breathing circuits were found leaking water prior to patient use.There was no patient involvement.

• Brand Name: VENTED AUTOFEED HUMIDIFICATION CHAMBER
• Type of Device: HUMIFICATION 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: 18620112
• MDR Text Key: 334882785
• Report Number: 9611451-2024-00066
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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,Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/08/2024
• 2 Devices were Involved in the Event: 1 2

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: MR20V
• Device Catalogue Number: MR290V
• Device Lot Number: SEE H11
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/08/2024
• Initial Date FDA Received: 01/31/2024
• Supplement Dates Manufacturer Received: 03/10/2024
• Supplement Dates FDA Received: 04/09/2024
• 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: Initial
• Patient Sequence Number: 1