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

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  

Event Description

Received call from mother of patient stating that the ipv device was not working properly.Attempted to troubleshoot equipment over the phone with no resolution.Scheduled home visit and arrived at patient's home to find ipv working for 2-3 minutes but started to slow down.Equipment replaced.

• 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: 6776515
• MDR Text Key: 82139376
• Report Number: 6776515
• 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: 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: Patient Family Member or Friend
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/04/2017
• Event Location: Home
• Date Report to Manufacturer: 08/04/2017
• 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.
• Patient Age: 4 YR
• Patient Weight: 3