MAUDE Adverse Event Report: ARJOHUNTLEIGH, INC. KINAIRMEDSURG

Model Number 201001W

Device Problem Noise, Audible (3273)

Patient Problem Death (1802)

Event Date 06/17/2014

Event Type  Death  

Event Description

We have received the info from a customer that one of our devices is making noise.Further arjohuntleigh assistance has been requested by the customer in order to check the issue of a blower being noisy.It appears that the issue has been raised by the facility after the pt passed away.

• Brand Name: KINAIRMEDSURG
• Manufacturer (Section D): ARJOHUNTLEIGH, INC.; 4958 stout drive; san antonio TX 78219
• Manufacturer (Section G): ARJO, INC.; 50 north gary ave., suite a; roselle IL 60172 168
• Manufacturer Contact: 50 north gary ave., suite a; roselle, IL 60172-1684
• MDR Report Key: 4336976
• MDR Text Key: 5139226
• Report Number: 1419652-2014-00334
• Device Sequence Number: 1
• Product Code: INX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 201001W
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/17/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death