MAUDE Adverse Event Report: RESMED CORP CPAP A MACHINE AND N30 MASK; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Device Problems Inadequacy of Device Shape and/or Size (1583); Use of Device Problem (1670); Fitting Problem (2183); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/24/2023

Event Type  malfunction  

Event Description

Adapt heath/ ocean breeze infusion center delivered the wrong equipment on may 24th.They sent out 2 technicians who brought the wrong mask and fitted me incorrectly.Since they brought the wrong equipment on may 24 i could not use the machine.They finally sent a person out on june 26th.He brought the wrong mask.This company is billing since may 24 for an item i could not use until june 26 because they supplied the wrong mask.I have called the company many times they say someone was going to call back on june 27th i spoke with (b)(4) in customer service.She told me a supervisor would call me back no one did.Yesterday i called and was told (b)(4) would call back and did not.They are fraudulently billing for services they do not provide.In may they sent out a technician.Before he came i confirmed he had the n30 mask.He said yes and comes without that mask.The mask they provided did not work and the technician had no idea what they are doing.He put the mask on backwards.I have never used a cpap machine and could have been harmed by this incompetence.So this company is not providing proper service and getting paid and they are billing for a service i did not receive because they provided the wrong equipment.Reference report: #mw5119020.

• Brand Name: CPAP A MACHINE AND N30 MASK
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED CORP
• MDR Report Key: 17239381
• MDR Text Key: 318358056
• Report Number: MW5119021
• 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: 06/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 63 KG