MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO CAPITAL HYPER HYPOTHERMIA; SYSTEM, THERMAL REGULATING

Catalog Number MTA6900

Device Problems Leak/Splash (1354); Improper Device Output (2953)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/01/2014

Event Type  malfunction  

Event Description

It was reported that the unit had current leakage that was out of specification due to a faulty solenoid valve and pcb board.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.

• Brand Name: CAPITAL HYPER HYPOTHERMIA
• Type of Device: SYSTEM, THERMAL REGULATING
• 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: brian thompson ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 4329467
• MDR Text Key: 5136100
• Report Number: 0001831750-2014-03410
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: MTA6900
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/19/2014
• 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