MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE, INC. TEMP PROBE FOR VENT; HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)

Model Number 900MR861

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn(s) (1757)

Event Date 12/10/2020

Event Type  Injury  

Event Description

Patient received a burn on her left cheek/ jawbone from a temp probe on her vent circuit.Fda safety report id # (b)(4).

• Brand Name: TEMP PROBE FOR VENT
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE, INC.
• MDR Report Key: 11036788
• MDR Text Key: 224841505
• Report Number: MW5098444
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 900MR861
• Device Catalogue Number: 900MR861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/17/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 7 YR