MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LIMITED RESPIRATORY HUMIDIFIER; BTT

Model Number HC550JHU

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems No Consequences Or Impact To Patient (2199); Obstruction/Occlusion (2422)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device evaluation anticipated, but not yet begun.We will provide a follow up report upon completion of our investigation.

Event Description

A healthcare facility in the uk reported via a fisher & paykel healthcare (f&p) field representative on behalf of a homecare patient, that an hc550 respiratory humidifier was allegedly delivering insufficient humidity which caused discomfort, desaturation, plugging off and thickening secretions and resulted to the patient being admitted to the hospital for an emergency trachea change.The hc550 respiratory humidifier was being used with an intersurgical breathing circuit, a bivona flextend tracheostomy tube and a resmed astral 100 ventilator.The patient's condition was reported to be stable and the patient has since returned home.

Event Description

A healthcare facility in the uk reported via a fisher & paykel healthcare (f&p) field representative on behalf of a homecare patient, that an f&p hc550 respiratory humidifier was allegedly delivering insufficient humidity which caused discomfort, desaturation, plugging off and thickening secretions and resulted to the patient being admitted to the hospital for an emergency tracheostomy change.The patient's condition was reported to be stable and the patient has since returned home.

Manufacturer Narrative

(b)(4).Method: the complaint hc550 respiratory humidifier was returned to the f&p regional office in the uk where a trained f&p service technician conducted a functional check as per the product technical manual.Results: there was no fault found with the complaint hc550 upon evaluation; the device performed within specification.Conclusion: the f&p hc550 respiratory humidifier was being used with an intersurgical breathing circuit at the time of the incident which may have contributed to the reported lack of humidity.The user instructions that accompany the hc550 state that, "the use of breathing circuits, chambers or other accessories which are not approved by fisher & paykel healthcare may impair performance or compromise safety." the user has been recommended to use fisher & paykel healthcare breathing circuits to optimize the humidity being delivered to the patient.

• Brand Name: RESPIRATORY HUMIDIFIER
• Type of Device: BTT
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• MDR Report Key: 7755320
• MDR Text Key: 116207889
• Report Number: 9611451-2018-00660
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• PMA/PMN Number: K132017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,user facilit
• Type of Report: Initial,Followup
• Report Date: 07/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: HC550JHU
• Device Catalogue Number: HC550JHU
• Device Lot Number: 2100068906
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BIVONA FLEXTEND TRACHEOSTOMY TUBE; BIVONA FLEXTEND TRACHEOSTOMY TUBE; INTERSURGICAL BREATHING CIRCUIT; INTERSURGICAL BREATHING CIRCUIT; RESMED ASTRAL 100 VENTILATOR; RESMED ASTRAL 100 VENTILATOR; BIVONA FLEXTEND TRACHEOSTOMY TUBE; INTERSURGICAL BREATHING CIRCUIT; RESMED ASTRAL 100 VENTILATOR
• Patient Outcome(s): Hospitalization
• Patient Age: 24 MO