MAUDE Adverse Event Report: STRYKER MEDICAL; BED

Device Problems Device Emits Odor (1425); Sparking (2595); Noise, Audible (3273)

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

Event Date 09/29/2014

Event Type  malfunction  

Event Description

Nurse went to elevate the head of bed for comfort.The bed was plugged in, and her scd machine was plugged into the outlet on the bed at the far end underneath the foot of the bed.When the nurse used the button to elevate the head of bed, sparks shot out from underneath the foot of the bed.At this point nothing was seen, just heard popping.When they tried again, the father was standing at the foot of the bed and saw the sparks shooting out.They immediately smelled smoke.The healthcare team unplugged the scd machine from the outlet and unplugged the bed from the wall.Charge nurse notified and patient was moved to new bed.Biomed was notified and the bed was assigned a work order.

• Type of Device: BED
• Manufacturer (Section D): STRYKER MEDICAL; 3800 e. centre ave; portage MI 49002
• MDR Report Key: 4253108
• MDR Text Key: 4992783
• Report Number: 4253108
• Device Sequence Number: 1
• Product Code: FNL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/15/2014
• Event Location: Hospital
• Date Report to Manufacturer: 11/15/2014
• Patient Sequence Number: 1