MAUDE Adverse Event Report: RESPIRONICS CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Device Problems Inadequate Instructions for Healthcare Professional (1319); Device Markings/Labelling Problem (2911)

Patient Problem No Information (3190)

Event Date 12/04/2017

Event Type  malfunction  

Event Description

Reporter states that on (b)(6) 2017 he received a cpap machine from respironics imported from (b)(4).Upon receiving the device he states that there were no markings on it and was unable to determine what voltage settings the device was on.He goes on to say that there was no information in the instruction booklet that came with the device.He has no other issues with the device.

• Brand Name: CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS
• MDR Report Key: 7247351
• MDR Text Key: 99351252
• Report Number: MW5075093
• 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: 02/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/06/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 90 YR
• Patient Weight: 83