MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD CLASSIC T-PIECE CIRCUIT; BTL

Model Number	900RD010
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Fisher & paykel healthcare (f&p) is 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 united kingdom reported via the medicines and healthcare products regulatory agency (mhra) that a deviation in the positive end-expiratory pressure (peep) value was observed during the resuscitation of a patient using a (b)(4).Adjustable t piece resuscitation circuit.The peep, which should ideally be maintained at 10 cm h2o was noted to be at an elevated level of 30 cm h2o.There were no patient consequences reported.F&p have requested further information about the event and patient condition.
Additional Manufacturer Narrative
(b)(4).The f&p classic t-piece circuit (900rd010) is a single use breathing circuit intended to provide ventilatory support to neonates and infants with respiratory insufficiency.The device is designed to connect to the f&p neopuff t-piece resuscitator or any other gas-powered resuscitator complaint to iso-10651-5:2006.This device is designed for use in the hospital environment and must be prescribed by a physician.It is intended to be used by medical professionals including physicians, nurses, midwives and respiratory therapists.Method: the complaint 900rd010 adjustable t piece resuscitation cirucit was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is based on the information provided by the customer and our knowledge of our product.Result: the customer reported a deviation in the positive end-expiratory pressure (peep) value was observed during the resuscitation of a patient using the 900rd010 adjustable t piece resuscitation circuit.Conclusion: without the complaint device, we are unable to determine the cause of the reported fault.The following general warnings have been included in the user instructions: the f&p classic t-piece circuit and f&p neopuff t-piece resuscitator are intended for use by medical professionals trained in infant resuscitation.Do not occlude the resuscitation tubing.Do not connect the t-piece circuit (900rd010) directly to a high-pressure gas source.The t-piece circuit must be connected to the outlet port of the neopuff or gas-powered resuscitator.Bypassing the resuscitation device may result in serious patient harm.
Event or Problem Description
A healthcare facility in united kingdom reported via the medicines and healthcare products regulatory agency (mhra) that a deviation in the positive end-expiratory pressure (peep) value was observed during the resuscitation of a patient using a 900rd010 adjustable t piece resuscitation circuit.The peep, which should ideally be maintained at 10 cm h2o was noted to be at an elevated level of 30 cm h2o.There were no patient consequences reported.F&p have requested further information about the event and patient condition.

• Brand Name: CLASSIC T-PIECE CIRCUIT
• Common Device Name: BTL
• 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: diego banuelos ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494534002
• MDR Report Key: 19199320
• Report Number: 9611451-2024-00335
• Device Sequence Number: 8072758
• Product Code: BTL
• UDI-Device Identifier: 09420012429933
• UDI-Public: (01)09420012429933(10)2102851227(11)231026
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2024

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
• Operator of Device: Health Professional
• Device Model Number: 900RD010
• Device Catalogue Number: 900RD010
• Device Lot Number: 2102851227
• 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: 04/10/2024
• Supplement Date Received by Manufacturer: 06/04/2024
• Initial Report FDA Received Date: 04/28/2024
• Supplement Report FDA Received Date: 06/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/26/2023
• 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
• Patient Sex: Unknown