MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO CONTROL UNIT AIRE SELECT; BED, FLOTATION THERAPY, POWERED

Catalog Number C2500

Device Problems Device Operates Differently Than Expected (2913); Temperature Problem (3022)

Patient Problem Swelling (2091)

Event Date 04/18/2016

Event Type  Injury  

Event Description

It was reported that the mattress was blowing hot air onto the patient allegedly causing blisters which required an application of ointment.

Manufacturer Narrative

Supplemental submitted to provide results of evaluation.The control unit passed the functional tests and no defect could be found.

Event Description

It was reported that the mattress was blowing hot air onto the patient allegedly causing blisters which required an application of ointment.

• Brand Name: CONTROL UNIT AIRE SELECT
• Type of Device: BED, FLOTATION THERAPY, POWERED
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer (Section G): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer Contact: mary klaver ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 5663685
• MDR Text Key: 45414479
• Report Number: 0001831750-2016-00167
• Device Sequence Number: 1
• Product Code: IOQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/22/2016

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?: Yes
• Device Operator: No Information
• Device Catalogue Number: C2500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/22/2016
• Initial Date FDA Received: 05/18/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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