MAUDE Adverse Event Report: PERCUSSIONAIRE CORP. PERCUSSIONAIRE; SINUSOIDAL BRONCHOTRON/MONITRON TRANSPORT

Model Number	F00038-2
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No damage found to unit, unit had very low flowrate upon start up.Also did not exceed the max 80+ cm/h2o, and expiratory time was out of calibration.Unit functioned, found no noticable leaks within the unit.Found no loose fittings, no pinched o-rings, no broken fittings or check valves.Found the multi meter to be functioning upon unit start up and all through testing.Distributor stated that the transport of the very sick patient on ecmo was a success even with the amount of gas the device used.
Event or Problem Description
Possible leak in device.Device used a full m tank in 2 and a half hours.Biomed personnel did a check with a fluke device and saw some leakage while they were running the machine.Shortly after this, the machine wasn't functioning correctly.

• Brand Name: PERCUSSIONAIRE
• Common Device Name: SINUSOIDAL BRONCHOTRON/MONITRON TRANSPORT
• Manufacturer (Section D): PERCUSSIONAIRE CORP.; 1655 glengary bay rd; sagle ID 83860
• MDR Report Key: 5757068
• Report Number: 1000524541-2016-00004
• Device Sequence Number: 1164119
• Product Code: CBK
• UDI-Device Identifier: 00849436000235
• UDI-Public: (01)00849436000235(11)151118
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K905234
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Respiratory Therapist
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 06/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: F00038-2
• Device Catalogue Number: S00033-2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2016
• Initial Report FDA Received Date: 06/28/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 12 YR