MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO CAPITAL BLOOD/FLUID WARMER; DEVICE, WARMING. BLOOD AND PLASMA

Catalog Number FW600U

Device Problems Device Operates Differently Than Expected (2913); Material Integrity Problem (2978)

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

Event Date 02/06/2014

Event Type  malfunction  

Event Description

It was reported by repair work order that the grounding path was compromised.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.

• Brand Name: CAPITAL BLOOD/FLUID WARMER
• Type of Device: DEVICE, WARMING. BLOOD AND PLASMA
• 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: anthony noora ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 3875055
• MDR Text Key: 19970211
• Report Number: 0001831750-2014-03067
• Device Sequence Number: 1
• Product Code: KZL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: FW600U
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/21/2014
• 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