MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD WATER FEEDSET; CAW

Model Number	900MR190
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).We are currently in the process of completing our investigation.We will provide a follow up report upon completion of our investigation.
Event or Problem Description
A healthcare facility in canada reported via a fisher & paykel healthcare (f&p) field representative, that the clamp of a 900mr190 water feedset was found broken during use causing the mr250 manual feed adult humidification chamber to overfill.It was also reported that the "water flowed into the patient's breathing circuit and into the patient's airway".There were no adverse patient outcomes reported as a result of this event.However, further information has been requested.
Additional Manufacturer Narrative
(b)(4).Method: the complaint: (b)(4) water feedset was not returned to fisher & paykel (f&p) healthcare for evaluation as it was discarded by the healthcare facility.Further information regarding the sequence of events and the patient outcome were requested however only limited information was provided.Our investigation is therefore based on the limited information provided by the customer and our knowledge of our product.Results: the healthcare facility reported that the clamp of a (b)(4) water feedset was found broken during use causing the mr250 manual feed adult humidification chamber to overfill.It was also reported that the "water flowed into the patient's breathing circuit and into the patient's airway".There were no adverse patient outcomes reported as a result of this event.Conclusion: without the return of the complaint device and further details on the sequence of events, we are unable to determine what may have caused the reported event.The (b)(4) water feedset allows the user to control filling of a humidification chamber using a self-closing clamp mechanism initially set open via a ring pin.To use the device, the pin is removed and discarded, the clamp is then set in a self closed position.To allow filling of the chamber, the clamp is manually squeezed open by the clinician and once the clamp is released the user should ensure that the water flow has stopped.All (b)(4) water feedsets are visually inspected and the function of the spring is checked prior to being released for distribution, and those that fail are rejected.The subject device would have met the required specifications at the time of production.The user instructions that accompany the (b)(4) water feedset include the following: "remove the ring pin from the self-closing clamp and discard the ring pin." "squeeze the clamp to allow the water to enter the humidification chamber.Fill the chamber to the indicated maximum water level.Do not overfill." "release the clamp to stop water flowing into the humification chamber.Ensure water flow has stopped." "after filling the humidification chamber, place the water source below the level of the humidification chamber.".
Event or Problem Description
A healthcare facility in canada reported via a fisher & paykel healthcare (f&p) field representative, that the clamp of a 900mr190 water feedset was found broken during use causing the mr250 manual feed adult humidification chamber to overfill.It was also reported that the "water flowed into the patient's breathing circuit and into the patient's airway".There were no adverse patient outcomes reported as a result of this event.However, further information has been requested.

• Brand Name: WATER FEEDSET
• Common Device Name: CAW
• 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: faranak gomarooni ; 15 maurice paykel place; east tamaki; auckland,, CA 2013 ; NZ 2013 ; 9494534000
• MDR Report Key: 16433244
• Report Number: 9611451-2023-00073
• Device Sequence Number: 7326073
• Product Code: BTL
• UDI-Device Identifier: 09420012429780
• UDI-Public: (01)09420012429780(10)2101859075(11)211021
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K892885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2023
• 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
• Operator of Device: Health Professional
• Device Model Number: 900MR190
• Device Catalogue Number: 900MR190
• Device Lot Number: 2101859075
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2023
• Supplement Date Received by Manufacturer: 03/08/2023
• Initial Report FDA Received Date: 02/23/2023
• Supplement Report FDA Received Date: 04/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: F&P MR250 MANUAL FEED ADULT HUMIDIFICATION CHAMBER.; F&P MR250 MANUAL FEED ADULT HUMIDIFICATION CHAMBER.
• Patient Sex: Unknown