MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD FISHER & PAYKEL; HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)

Model Number RT210

Device Problems Leak/Splash (1354); Pressure Problem (3012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/20/2015

Event Type  malfunction  

Event Description

Biomed received call to check out a ventilator that was not holding pressure.The complaint on the ticket was "device has big failure leak".Respiratory therapist was pre-testing a ventilator and failed its leak test.Biomedical engineering technician tested unit and it failed the leak test two times.Leak was traced to accessories.A fisher&paykel part number rt210 (adult ventilator circuit dual heated with mr290 auto feed chamber).The lead was coming from the mr 290 chamber included in the unit.A second accessory pack was open and tested and same leak was noticed.

• Brand Name: FISHER & PAYKEL
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15365 barranca pkwy; irvine CA 92618
• MDR Report Key: 5041749
• MDR Text Key: 24543978
• Report Number: 5041749
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Report Date: 08/28/2015

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: Other
• Device Model Number: RT210
• Device Catalogue Number: RT210
• Device Lot Number: 1411210301
• Other Device ID Number: (01)09420012417244(10)1411210
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/28/2015
• Event Location: Hospital
• Date Report to Manufacturer: 08/28/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/31/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1