MAUDE Adverse Event Report: HEATED OXYGEN THERAPY KIT; BTT

Model Number RT308

Device Problems Leak/Splash (1354); Failure of Device to Self-Test (2937)

Patient Problem No Patient Involvement (2645)

Event Date 11/11/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We are currently in the process of obtaining further information related to the reported event.We will provide a follow up report upon completion of our investigation.

Event Description

A healthcare facility in (b)(6) reported, via a fisher & paykel healthcare (f&p) field representative, that an rt308 heated oxygen therapy kit failed a ventilator leak test before use.There was no patient involvement.

Manufacturer Narrative

(b)(4).Method: the complaint rt308 heated oxygen therapy kit was not returned to fisher & paykel healthcare (f&p) for evaluation.Our investigation is thus based on the information provided by the customer.Conclusion: customer reported that a ventilator alarm turned on when connected to an rt308 circuit.Without the return of the complaint device or further information regarding this event, we are unable to determine the cause of the reported fault.All rt308 oxygen therapy kit are visually inspected, and those that fail are rejected.The subject breathing circuit would have met the required specifications at the time of production.

Event Description

A healthcare facility in china reported, via a fisher & paykel healthcare (f&p) field representative, that an rt308 heated oxygen therapy kit failed a ventilator leak test before use.There was no patient involvement.

• Brand Name: HEATED OXYGEN THERAPY KIT
• Type of Device: BTT
• MDR Report Key: 9528583
• MDR Text Key: 181955692
• Report Number: 9611451-2019-01258
• 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: 11/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RT308
• Device Catalogue Number: RT308
• Device Lot Number: 2100755887
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/25/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1