MAUDE Adverse Event Report: PERCUSSIONAIRE CORP. PERCUSSIONAIRE; A50094-D SINGLE PATIENT PHASITRON KIT

Model Number	A50094-D
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was not returned, nor would initial reporter respond to our requests for more information.Without being given the lot number or manufacture date, we cannot conduct a thorough investigation, other than confirming that our devices are currently being assembled within specifications.
Event or Problem Description
Phasitron separated at weld while in use.

• Brand Name: PERCUSSIONAIRE
• Common Device Name: A50094-D SINGLE PATIENT PHASITRON KIT
• Manufacturer (Section D): PERCUSSIONAIRE CORP.; 1655 glengary bay rd; sagle ID 83860
• MDR Report Key: 5699445
• Report Number: 1000524541-2016-00003
• Device Sequence Number: 432526
• Product Code: CBK
• UDI-Device Identifier: 00849436000259
• UDI-Public: 00849436000259
• Combination Product (Y/N): N
• PMA/510(K) Number: K905235
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Respiratory Therapist
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 05/12/2016

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: No Information
• Device Model Number: A50094-D
• Device Catalogue Number: A50094-D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2016
• Initial Report FDA Received Date: 06/03/2016
• 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; Required Intervention