MAUDE Adverse Event Report: PHILIPS/ RESPIRONICS MEDICAL PRODUCTS HOLDING CHAMBERS, DIRECT PATIENT INTERFACE

Model Number 00

Device Problem Use of Device Problem (1670)

Patient Problem Insufficient Information (4580)

Event Date 12/31/2020

Event Type  Injury  

Event Description

A reporter called to report an adverse event as a result of using a wrong device which was given to them by a (b)(6) pharmacist.Her grandson was prescribed for a nebulizer for his bronchitis.However, the pharmacist gave them a spacer for inhaler.She said the pharmacist did this intentionally because when he was asked that was not her grandson's prescription, he claimed it should work the same way.The reporter said as a result her grandson's condition worsen since he did not get his medication as he should.The reporter said since she is a registered nurse, she figured out that it was a wrong device and corrected the problem.

• Brand Name: HOLDING CHAMBERS, DIRECT PATIENT INTERFACE
• Type of Device: HOLDING CHAMBERS, DIRECT PATIENT INTERFACE
• Manufacturer (Section D): PHILIPS/ RESPIRONICS MEDICAL PRODUCTS
• MDR Report Key: 11125318
• MDR Text Key: 225560240
• Report Number: MW5098695
• Device Sequence Number: 1
• Product Code: NVP
• UDI-Device Identifier: 00383730000145
• UDI-Public: (01)00383730000145(10)PS007141(11)190404
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 01/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 00
• Device Catalogue Number: 1097502
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 10 MO
• Patient Weight: 8