MAUDE Adverse Event Report: PHILIPS / RESPIRONICS, INC. PHILIPS RESPIRONICS DREAM/WEAR UNDER THE NOSE NASAL MASK; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number 1116707

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 02/07/2020

Event Type  malfunction  

Event Description

A medical device primary package label states a size that is different from the size labeled on the actual medical device.The device is a nasal, under the nose frame for use with a cpap machine.A medium size nose frame was ordered from the supplier.On receipt of the item from the supplier, the outer label on the front of the device primary package stated "l" (large) size.Didn't open the hermetically seated package.Contacted the supplier, stated problem, supplier instructed to return item and that the item would be picked up by someone.The supplier stated will resend correct size (medium).Several days later, before anyone picked the item, the supplier called and instructed to open the hermetically sealed package and look to see if the actual item was marked medium.The item is marked "med".Supplier instructed that the item is actually a medium (the size originally ordered), to go ahead and use the item and to not return the item after all.Item is used with cpap machine for significant sleep apnea condition.Fda safety report id# (b)(4).

• Brand Name: PHILIPS RESPIRONICS DREAM/WEAR UNDER THE NOSE NASAL MASK
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 9706352
• MDR Text Key: 179432646
• Report Number: MW5092969
• 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: Patient
• Type of Report: Initial
• Report Date: 02/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1116707
• Device Catalogue Number: U/K
• Device Lot Number: 190708
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 104