MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE, LTD. 850 SYSTEM TEMPERATURE/FLOW PROBE; HUMIDIFIER, RESPIRATORY GAS

Catalog Number 900MR869

Device Problem Detachment Of Device Component (1104)

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

Event Date 10/30/2015

Event Type  malfunction  

Event Description

Gray connector to ventilator hook became unattached.

• Brand Name: 850 SYSTEM TEMPERATURE/FLOW PROBE
• Type of Device: HUMIDIFIER, RESPIRATORY GAS
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE, LTD.; 15365 barranca pkwy; irvine CA 92618
• MDR Report Key: 5276651
• MDR Text Key: 32986728
• Report Number: 5276651
• 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
• Type of Report: Initial
• Report Date: 11/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 900MR869
• Device Lot Number: 00MX86905212
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/12/2015
• Event Location: Hospital
• Date Report to Manufacturer: 11/12/2015
• 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
• Patient Outcome(s): Other
• Patient Age: 71 YR
• Patient Weight: 78