MAUDE Adverse Event Report: PHILIPS / RESPIRONICS, INC. PHILIPS REPIRONICS SUPPLIES CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Device Problems Component Missing (2306); Tear, Rip or Hole in Device Packaging (2385)

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

Event Date 05/24/2022

Event Type  malfunction  

Event Description

Cpap supplies received in the mail.The enclosed packages had holes in them and one package cut opened and part of the contents were missing.When i called supplier, they told me they needed part of my package for other consumers and nothing they sent me was sterile.Now i'm wondering what crap are they spreading over my medical supplies before i get them? hmmmm.Another lawsuit after the supplier spreads the germs to us? what can we do about it? fda safety report id# (b)(4).

• Brand Name: PHILIPS REPIRONICS SUPPLIES CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 14547427
• MDR Text Key: 293078605
• Report Number: MW5109971
• 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: 05/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2022
• 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: 72 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic