MAUDE Adverse Event Report: PEDIATRIC COMPRESSOR NEBULIZER PROBASICS

Model Number PUFF NEB 8010

Device Problems Melted (1385); Overheating of Device (1437); Device Unsafe to Use in Environment (2918); Protective Measures Problem (3015)

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

Event Date 09/11/2014

Event Type  malfunction  

Event Description

We received a child nebulizer (was a penguin) from our local medical supply store.After a couple of uses i noticed the tubing was hot during use, really hot, too hot to touch.So hot that it melted the tubing.We took it back today and were informed this has not been the only one returned because of this issue.These are designed for children (animal characters), they are attached to a child's face and then an electrical outlet, and then gets hot.This, to me, seems it could be a fire hazard and should be recalled before a child get gets injured or worse.(b)(4).(b)(6).

• Brand Name: PEDIATRIC COMPRESSOR NEBULIZER PROBASICS
• Type of Device: PEDIATRIC COMPRESSOR NEBULIZER PROBASICS
• MDR Report Key: 4117364
• MDR Text Key: 4941656
• Report Number: MW5038321
• Device Sequence Number: 1
• Product Code: CAF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 09/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: PUFF NEB 8010
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1