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

Model Number 900MR869

Device Problems Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)

Patient Problem Death (1802)

Event Date 02/17/2020

Event Type  Death  

Manufacturer Narrative

(b)(4).We are in the process of obtaining further information from the customer to determine if the 900mr869 temperature/flow probe caused or contributed to the reported event.We will provide a follow up report upon completion of the investigation.

Event Description

A healthcare facility in ontario reported via a fisher & paykel healthcare (f&p) representative that a 900mr869 temperature/flow probe dislodged from a breathing circuit during use.It was further reported that the interruption in ventilation contributed to the patient, who was critically ill and unstable, to deteriorate.The patient went into organ failure and deceased.

Manufacturer Narrative

(b)(4).Method: the complaint 900mr869 temperature/flow probe was not returned to fisher & paykel healthcare in new zealand for evaluation.Additional information was received from the customer.Our investigation is thus based on the information provided by the customer, and our knowledge of the product.Results: the customer reported that the (b)(4) temperature/flow probe dislodged from a breathing circuit during use.The patient subsequently deceased.The customer clarified that the reported dislodgment of the complaint 900mr869 temperature/flow probe was likely due to the customer's technicians altering the geometry of the probe, by grinding down a feature of the probe (plastic v-shaped notch), which affected the secure fit of the probe into the chamber.The customer reported they performed this so that their staff could disconnect the probe more easily.Conclusion: based on the additional information provided by the customer, the probe dislodgment was most likely due to the customer altering the geometry of the probe's chamber end.Our user instructions provide a visual depiction of the probe being correctly inserted into the chamber as part of the set up instructions.This depiction shows the function of the v-shaped notch to fit correctly into the chamber end, ensuring a tight secure fit.However, without the complaint device we were unable to definitively determine the cause of the reported event.The user instructions which accompany the (b)(4) temperature probe states: - "visually inspect entire product for damage before use.Discard if damaged." - "ensure that temperature probe sensors are correctly and securely fitted." "probe maintenance and accuracy checks should be routinely performed.For further information, refer to the mr850 technical manual (available from your local fisher & paykel healthcare representative)." - "failure to perform routine probe accuracy and visible damage checks may impair performance or compromise safety.".

Event Description

A healthcare facility in ontario reported via a fisher & paykel healthcare (f&p) representative that a 900mr869 temperature/flow probe dislodged from a breathing circuit during use.It was further reported that the interruption in ventilation contributed to the patient, who was critically ill and unstable, to deteriorate.The patient went into organ failure and deceased.

• 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
• MDR Report Key: 9876221
• MDR Text Key: 184799408
• Report Number: 9611451-2020-00309
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• PMA/PMN Number: K983112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 900MR869
• Device Catalogue Number: 900MR869
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death