MAUDE Adverse Event Report: MEDISIZE BV, EDISONSTRAAT 1 MEDISIZE HME TRACH P AND VALVE; CONDENSER, HEAT AND MOISTURE

Model Number MS-133

Device Problems Use of Device Problem (1670); Misassembly by Users (3133)

Patient Problem Choking (2464)

Event Date 05/08/2015

Event Type  malfunction  

Event Description

Pediatric patient removed diaphragm/valve disc located on top of device and placed in mouth.Patient began gagging and choking nurse/mother visualized piece in the back of the patient's mouth and removed it.The patient's condition was not affected by this incident.

• Brand Name: MEDISIZE HME TRACH P AND VALVE
• Type of Device: CONDENSER, HEAT AND MOISTURE
• Manufacturer (Section D): MEDISIZE BV, EDISONSTRAAT 1; ab hillegom 2181 ; NL 2181
• Manufacturer Contact: 15011 herriman blvd.; noblesville, IN 46060 ; 3177763175
• MDR Report Key: 4849985
• MDR Text Key: 15575287
• Report Number: 1824226-2015-00002
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: CLASS I
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MS-133
• Device Catalogue Number: MS-133
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other