MAUDE Adverse Event Report: PERCUSSIONAIRE CORP. PERCUSSIONAIRE; IPV HC

Model Number F00012-HT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 07/24/2017

Event Type  malfunction  

Manufacturer Narrative

The ipv hc is a homecare therapy device for airway clearance.The suspect device was returned to the distributor's biomed technician, who completed the investigation.The device was investigated and functional tested with no issues noted, and subsequently returned into service.During the technician's investigation, no evidence of heat or smoke was found on or in the device.The only anomolies noted were that the gray outer layer of the power cord insulation was shifted, and exposed a bit more of the inner wires' insulation than typical, though the insulation on the inner wires was intact, with no copper wires showing.Also, the fan grills were missing, and the filter cap was missing.This was not a reportable event, but we decided to file this mdr so that our response to the end user's report would be on record.

Event Description

Home health nurse reported that the device was hot and smoking, and that the wires on the unit's connector were frayed.

• Brand Name: PERCUSSIONAIRE
• Type of Device: IPV HC
• Manufacturer (Section D): PERCUSSIONAIRE CORP.; 1655 glengary bay rd.; sagle ID 83860
• Manufacturer (Section G): PERCUSSIONAIRE CORP.; 1655 glengary bay rd.; sagle ID 83860
• Manufacturer Contact: shawn burns ; 1655 glengary bay rd.; sagle, ID 83860 ; 2082632549
• MDR Report Key: 6962415
• MDR Text Key: 90753345
• Report Number: 1000524541-2017-00004
• Device Sequence Number: 1
• Product Code: NHJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K905236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 10/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Home Health Aide
• Device Model Number: F00012-HT
• Device Catalogue Number: S00009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 8 YR
• Patient Weight: 29