MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD TEMPERATURE/FLOW PROBE; BTT

Model Number 900MR869

Device Problem Disconnection (1171)

Patient Problem Low Oxygen Saturation (2477)

Event Type  malfunction  

Event Description

A hospital in the (b)(6) reported to a fisher & paykel healthcare (fph) representative that a 900mr869 temperature/flow probe became disconnected from the rt330 infant optiflow circuit during use.They further reported that the patient began to desaturate.

Manufacturer Narrative

(b)(4).Our investigation is currently in progress.We will provide a follow up report upon completion of our investigation.

Manufacturer Narrative

(b)(4).Method: the complaint 900mr869 temperature probe was not returned to fisher & paykel healthcare in (b)(4) for evaluation.Therefore, our investigation is based on the information provided by the hospital, information gathered by an fph representative during a visit to the hospital, and our knowledge of the product.Results: during the fph rep's visit it was noticed that the hospital staff were not completely pushing in the 900mr869 temperature probe.Conclusion: without the return of the complaint device we are unable to determine the root cause of the problem reported by the customer.However, the reported disconnection was most likely due to the temperature probe not properly inserted into the inspiratory limb of the rt330 infant optiflow circuit.Since the reported incident a fisher & paykel healthcare representative has visited the hospital and has provided additional training on the correct placement of the temperature probes.We have had no further reports from this hospital.The user instructions that accompany the 900mr869 temperature probe state: "the probes must also be pushed firmly into the probe ports on the inspiratory side of the breathing circuit and the key on the chamber outlet probe must align with the probe port key-way.Furthermore, the user instructions that accompany the rt330 infant optiflow circuit state: "check that all connections, caps and/or plugs are tight before use." "patient monitoring is recommended.".

Event Description

A hospital in the (b)(6) reported to a fisher & paykel healthcare (fph) representative that a 900mr869 temperature/flow probe became disconnected from the rt330 infant optiflow circuit during use.They further reported that the patient began to desaturate.

• Brand Name: TEMPERATURE/FLOW PROBE
• Type of Device: BTT
• 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: raymond yan ; 15365 barranca parkway; irvine, CA 92618-2216 ; 9494534000
• MDR Report Key: 3852448
• MDR Text Key: 4681495
• Report Number: 9611451-2014-00491
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K892885
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/07/2014

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: 900MR869
• Device Catalogue Number: 900MR869
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/07/2014
• Initial Date FDA Received: 06/05/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: FPH RT330 INFANT OPTIFLOW CIRCUIT; FPH MR850 RESPIRATORY HUMIDIFIER; FPH RT330 INFANT OPTIFLOW CIRCUIT; FPH MR850 RESPIRATORY HUMIDIFIER