MAUDE Adverse Event Report: RESPIRONICS, INC./ PHILIPS I-NEB + MED CHAMBER 5MCG PURPL; NEBULIZER (DIRECT PATIENT INTERFACE)

Device Problems Break (1069); Device Displays Incorrect Message (2591)

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

Event Type  malfunction  

Event Description

Patient states the i-neb was dropped and the sensor part cover broke off and device screen is now showing an error 66 even though she is holding the device at the right angle.Did the reported product fault occur while in use with the pt? yes.Did the product issue cause or contribute to pt or clinical injury? no.Is the actual device available for investigation? yes.Did we (mfr) replace the device? yes.No further info provided.Reported to (b)(6) by pt/caregiver.

• Brand Name: I-NEB + MED CHAMBER 5MCG PURPL
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): RESPIRONICS, INC./ PHILIPS
• MDR Report Key: 10301416
• MDR Text Key: 199884437
• Report Number: MW5095613
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1