MAUDE Adverse Event Report: PHILLIPS INEB

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 12/23/2015

Event Type  malfunction  

Event Description

Pts device would continue administering medication between breaths and would do so very quickly.No other info available.

• Brand Name: INEB
• Type of Device: INEB
• Manufacturer (Section D): PHILLIPS ; andover MA
• MDR Report Key: 5403616
• MDR Text Key: 37357190
• Report Number: MW5059815
• 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: 12/23/2015

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: Lay User/Patient
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/29/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 58 YR