MAUDE Adverse Event Report: UNKNOWN C-PAP MACHINE; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Device Problems Break (1069); Material Split, Cut or Torn (4008)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Pt called stating that the plastic tubing from their c pap machine that pushes air to their mask tore and ripped.Pt realized that they called the wrong number.Ps did not ask for event date or hcp information as the reason for call was not related to their medtronic device.(b)(4) this report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: C-PAP MACHINE
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17535253
• MDR Text Key: 321272235
• Report Number: MW5142152
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1