MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE INC. F&P ESON 2 NASAL MASK MEDIUM A FOR CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number ESN2MA

Device Problems Loose or Intermittent Connection (1371); Material Split, Cut or Torn (4008)

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

Event Date 01/01/2020

Event Type  malfunction  

Event Description

Hook and loop fastener on f&p eson 2 nasal mask headset ripped loose.Fda safety report id# (b)(4).

• Brand Name: F&P ESON 2 NASAL MASK MEDIUM A FOR CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE INC.
• MDR Report Key: 9559232
• MDR Text Key: 174113165
• Report Number: MW5092069
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: No Information
• Type of Report: Initial
• Report Date: 01/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ESN2MA
• Device Catalogue Number: ESN2MA
• Device Lot Number: 2100898529
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 73 YR
• Patient Weight: 100