MAUDE Adverse Event Report: RESMED CORP. AIRFIT F20; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Device Problems Break (1069); Product Quality Problem (1506); Contamination /Decontamination Problem (2895); Device Markings/Labelling Problem (2911)

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

Event Date 06/06/2022

Event Type  Injury  

Event Description

Broken product, mislabeled, possibly adulterated, imminent health risk: a bracket piece that is attached to the main mask and which the headgear straps to broke.It is unusable.I contacted the supplier performance home medical and sent them a pic but am unsure if they will actually let the manufacturer resmed know, so far they have not followed thru with anything they promised and i am unable to get through to them.The entire setup in new, he (my husband) just started cpap on (b)(6) 2022.But the packaging for the product is incorrect and the manufacturer needs to know that for the quality control investigation.The supplier kindly put a medium sized headgear into a large sized box after removing the large headgear/mask, but failed to pass on any labeling information so i do not even know the lot number or expiration date.It seems like it was just something they had laying around, possibly from a demo? but at least he had something to go home with.It may end up causing a serious adverse event, because the cardiologist states that if he does not use the cpap machine his afib will come back, "guaranteed." then his only option will be a pacemaker, and loss of his livelihood.They were supposed to ship new product overnight but they did not, per usps, the soonest we will see it is on monday, almost a week later.The product is mislabeled, they may have given me used product instead of new, so it may be unsanitary, adulterated, or compromised in some way, why else would it break like that if it were new? i will provide pics, and i give permission to be contacted by the fda or the manufacturer resmed.Thank you very much.Fda safety report id# (b)(4).

• Brand Name: AIRFIT F20
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESMED CORP.
• MDR Report Key: 14695765
• MDR Text Key: 294173043
• Report Number: MW5110328
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 06/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/14/2022
• Patient Sequence Number: 1
• Treatment: ATORVASTATIN; CHOLCHICINE (TAKING FOR 2 WEEKS ONLY POST EVENT); LASIX; LISINOPRIL; NEXIUM; PLAVIX; XERALTO
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White