MAUDE Adverse Event Report: PHILIPS RESPIRONICS INEB AAD SYSTEM

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Ineb is not beeping.No other info is known.

• Brand Name: INEB AAD SYSTEM
• Type of Device: INEB AAD SYSTEM
• Manufacturer (Section D): PHILIPS RESPIRONICS
• MDR Report Key: 5403611
• MDR Text Key: 37353734
• Report Number: MW5059814
• Device Sequence Number: 1
• Product Code: CAF
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 01/26/2016

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?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/28/2016
• Type of Device Usage: N
• Patient Sequence Number: 1