MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO ELECTRIC MED/SURG BED; BED, AC-POWERED ADJUSTABLE HOSPITAL

Catalog Number FL23E

Device Problems Fire (1245); Sparking (2595); Material Deformation (2976)

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

Event Date 01/20/2017

Event Type  malfunction  

Event Description

It was reported that the power plug sparked causing fire in the hospital's wall and possibly a burnt power plug and/or power prong.It was also reported that the casters were delaminating, causing the bed to have reduced brake force.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.

Manufacturer Narrative

Although it was originally reported that this product caused a fire, upon investigation it was determined that there were cracked power prongs which lead to a spark, but that there was no fire.The power cord was replaced for the customer, but they declined to have the casters repaired at this time.

Manufacturer Narrative

Manufacturing location for device corrected.

Event Description

It was originally reported that the power plug sparked causing fire in the hospital's wall and possibly a burnt power plug and/or power prong.However, upon evaluation it was found that although the power prongs were cracked causing a spark, there was no fire associated with this product.It was also reported that the casters were delaminating, causing the bed to have reduced brake force.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.

Event Description

It was originally reported that the power plug sparked causing fire in the hospital's wall and possibly a burnt power plug and/or power prong.However, upon evaluation it was found that although the power prongs were cracked causing a spark, there was no fire associated with this product.It was also reported that the casters were delaminating, causing the bed to have reduced brake force.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.

• Brand Name: ELECTRIC MED/SURG BED
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• 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: chanda burghard ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 6340569
• MDR Text Key: 68041622
• Report Number: 0001831750-2017-00038
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: FL23E
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/20/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/25/2005
• 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