MAUDE Adverse Event Report: PERCUSSIONAIRE CORP IPV PERCUSSIONATOR FAMILY AND ACC; DEVICE, POSITIVE PRESSURE BREATHING, INTERMITTENT

Device Problems Smoking (1585); Temperature Problem (3022)

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

Event Date 07/24/2017

Event Type  malfunction  

Event Description

The home health nurse noticed that the ipv unit was hot and smoking.The unit was stopped immediately and unplugged.The equipment was cleaned, tested and replaced.Frayed wires on the unit's connector was identified.

• Brand Name: IPV PERCUSSIONATOR FAMILY AND ACC
• Type of Device: DEVICE, POSITIVE PRESSURE BREATHING, INTERMITTENT
• Manufacturer (Section D): PERCUSSIONAIRE CORP; 1655 glengary bay rd; sagle ID 83860
• MDR Report Key: 6776565
• MDR Text Key: 82140020
• Report Number: 6776565
• Device Sequence Number: 1
• Product Code: NHJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/31/2017,08/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2017
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/31/2017
• Event Location: Home
• Date Report to Manufacturer: 07/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO OTHER DEVICES WERE BEING USED ON THE PATIENT AT; NO OTHER THERAPIES
• Patient Age: 8 YR
• Patient Weight: 29