MAUDE Adverse Event Report: PERCUSSIONAIRE CORPORATION PERCUSSIONAIRE; DEVICE, POSITIVE PRESSURE BREATHING, INTERMITTENT

Model Number F00001-C

Device Problem Protective Measures Problem (3015)

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

Event Date 09/16/2018

Event Type  malfunction  

Event Description

Ipv unit ceased "pulsatile" function.Unit only blows continuous stream of air.

• Brand Name: PERCUSSIONAIRE
• Type of Device: DEVICE, POSITIVE PRESSURE BREATHING, INTERMITTENT
• Manufacturer (Section D): PERCUSSIONAIRE CORPORATION; 130 mcghee rd ste 109; sandpoint ID 83864
• MDR Report Key: 7937752
• MDR Text Key: 122799210
• Report Number: 7937752
• Device Sequence Number: 1
• Product Code: NHJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: F00001-C
• Device Catalogue Number: S00002-C
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/28/2018
• Event Location: Hospital
• Date Report to Manufacturer: 10/05/2018
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 15695 DA