MAUDE Adverse Event Report: PRISM MEDICAL P440/P600 SONEIL CHARGER 24V, 1.0A W/XLR

Model Number 2403SRM 20

Device Problem Sparking (2595)

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

Event Date 03/11/2016

Event Type  malfunction  

Manufacturer Narrative

Outcome of investigation is pending reciept of unit to evaluate.A final report will be submitted upon completion.

Event Description

The power connector is sparking.

Manufacturer Narrative

The charger was returned on april 6, 2016 via (b)(4).Prism investigation: when the charger was plugged in, the led became green.When the charger was plugged into a demo unit, it would or would not transmit power based on how the connector was oriented.When the connector was twisted, the charger would make a "pop" sound; during this movement, the charger led would change from off - green - red.The voltage measured approximately 26 v, but was variable dependent on how the connector was oriented.Root cause: this connector design passed pull testing, the effect of gravity from the weight of the charger's body, puts perpendicular stress on the connector over time.Corrective action: the charger was replaced for customer.An external heat shrink tube with adhesive was added around the connection point, through ecr 1052, released on august 26, 2016.This tube will be added to all p440 chargers going forward.

• Brand Name: P440/P600 SONEIL CHARGER 24V, 1.0A W/XLR
• Type of Device: CHARGER
• Manufacturer (Section D): PRISM MEDICAL; 10888 metro court; maryland heights MO 63043
• Manufacturer (Section G): PRISM MEDICAL; 10888 metro court; maryland heights MO 63043
• Manufacturer Contact: steve kilburn ; 10888 metro court; maryland heights, MO 63043 ; 3142198614
• MDR Report Key: 5544546
• MDR Text Key: 42099522
• Report Number: 3007802293-2016-00054
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/28/2016

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
• Device Operator: No Information
• Device Model Number: 2403SRM 20
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/11/2016
• Initial Date FDA Received: 04/04/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/11/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1