MAUDE Adverse Event Report: COVIDIEN SHILEY; PHONATE VALVE SSV BX1

Model Number SSV

Device Problems Deflation Problem (1149); Device Operates Differently Than Expected (2913)

Patient Problem Death (1802)

Event Type  Death  

Manufacturer Narrative

(b)(4).The customer did not retain the lot number.The date of manufacture cannot be determined.Medtronic technical support has reviewed the shiley directions for use for ssv and ssvo speaking valve with the reporting physician during a phone discussion.The shiley directions for use for ssv and ssvo speaking valve indicate: on page 2 description: the ssv shiley speaking valve and the ssvo shiley speaking valve with oxygen port are devices with a one-way flutter valve and 15mm femail adapter for use with an appropriately fenestrated or a cuffless tracheostomy tube.On page 3 under warnings: the tracheostomy tube cuff must be completely deflated before placing the shiley speaking valve.Patient will be unable to breathe if cuff is not completely deflated.The event is not device related in that the warnings and ifu were not followed.Patient information (id, age, sex, weight) as well as additional information associated with the complaint have been requested and is either unknown, will not be made available to medtronic, or will be provided and updated in a supplemental report.

Event Description

The physician reported that an incident occurred during use of the speaking valve that resulted in a patient death.The cuff of the tracheostomy tube had not been deflated or completely deflated by the nurse when the speaking valve was used.

• Brand Name: SHILEY
• Type of Device: PHONATE VALVE SSV BX1
• Manufacturer (Section D): COVIDIEN; avenida henequen; 1181 parque industrial salvarcar; cd. juarez, chihuahua ; MX
• Manufacturer (Section G): COVIDIEN; avenida henequen; 1181 parque industrial salvarcar; cd. juarez, chihuahua ; MX
• Manufacturer Contact: thom mcnamara ; 15 hampshire street; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 5700715
• MDR Text Key: 46594849
• Report Number: 2936999-2016-00396
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K945407
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SSV
• Device Catalogue Number: SSV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death