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

Model Number F00012-HT

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 07/28/2017

Event Type  malfunction  

Manufacturer Narrative

The ipv hc is a homecare therapy device for airway clearance.The suspect device was returned to the hospital's biomed technician, who completed the investigation.The device was investigated and functional tested to manufacturer's specifications with no issues noted, and subsequently returned into service.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.For further details.

Event Description

Initial reporter indicated that device was not working properly, and would shut down after a few minutes of use.

• 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: 6926606
• MDR Text Key: 90107097
• Report Number: 1000524541-2017-00003
• 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: 10/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Patient Family Member or Friend
• 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: 06/29/2015
• 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: 4 YR
• Patient Weight: 3