MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD ADULT OXYGEN THERAPY BREATHING CIRCUIT; BTT

Model Number RT203

Device Problems Disconnection (1171); Infusion or Flow Problem (2964)

Patient Problems Death (1802); Low Oxygen Saturation (2477)

Event Date 05/07/2014

Event Type  Death  

Event Description

A hospital in (b)(6) reported via the (b)(6), that an rt203 adult oxygen therapy breathing circuit became disconnected from a unomedical aerosol adult mask during use.The patient was terminally ill due to respiratory problems.It was reported that the patient died, possibly as a result of lack of oxygen.

Manufacturer Narrative

The rt203 adult oxygen therapy breathing circuit is not sold in the usa but it is similar to a product which is sold in the usa.The 510(k) for that product is k983112.The complaint rt203 breathing circuit was not returned to fisher & paykel healthcare (fph) (b)(4) for evaluation as it was discarded by the hospital.Our investigation is therefore based on information provided by the hospital.Following receipt of this complaint an fph field representative visited the hospital to gain more information.The representative met with hospital staff and the supplier of the mask.The hospital informed the representative that there was no issue with the rt203.The rt203 is manufactured with a 22mm female connector which conforms to the standard iso 5356-1 for conical connectors.From the photographs provided by the hospital, it appears the unomedical mask model involved in this report does not have the same iso 5356-1 conical connector.Therefore the use of these two products together was incompatible.The hospital is working with the mask supplier to address this issue and considering switching to a fisher & paykel healthcare product instead.An fph representative is providing further training and support regarding the correct use and compatibility of the rt203 and its iso 5356-1 conical connectors.All breathing circuits are pressure tested for leaks during production and those that fail are rejected.Our user instructions that accompany the rt203 adult dual-heated breathing circuit state the following: - "check all connections are tight before use.".

• Brand Name: ADULT OXYGEN THERAPY BREATHING CIRCUIT
• 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: 3943086
• MDR Text Key: 4642695
• Report Number: 9611451-2014-00618
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K983112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: RT203
• Device Catalogue Number: RT203
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/24/2014
• Initial Date FDA Received: 07/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: UNOMEDICAL AEROSOL MASK
• Patient Outcome(s): Death