MAUDE Adverse Event Report: STRYKER MEDICAL MISTRAL AIR-PLUS; SYSTEM, THERMAL REGULATING

Model Number MA1100-PM

Device Problems Fire (1245); Melted (1385); Split (2537)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/14/2014

Event Type  malfunction  

Event Description

Masking tape found on patient warmer wrapped around hosing.Tape caught fire and was immediately put out.No harm to patient or personnel.Warmer removed from service.From bio-med: stryker model ma1100-pm (mistral air) is the device we noted that nearly started a fire.What appeared to happen was there had been a split in the heater hose, which staff placed some tape on it to seal the air.That tape acted as the combustible material which then caused the purple plastic to melt.

• Brand Name: MISTRAL AIR-PLUS
• Type of Device: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): STRYKER MEDICAL; 3800 e. centre ave.; portage MI 49002
• MDR Report Key: 4062551
• MDR Text Key: 20655519
• Report Number: 4062551
• Device Sequence Number: 1
• Product Code: DWJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Model Number: MA1100-PM
• Device Catalogue Number: MA1100-PM
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/18/2014
• Event Location: Hospital
• Date Report to Manufacturer: 09/05/2014
• Patient Sequence Number: 1
• Treatment: NO.