MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO SECURE 3 MED/SURG BEDOBS 01/13; BED, AC-POWERED ADJUSTABLE HOSPITAL

Catalog Number 3002S3EX

Device Problems Detachment Of Device Component (1104); Failure to Power Up (1476)

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

Event Date 01/07/2014

Event Type  malfunction  

Event Description

It was reported via repair work order that there was no power to the bed due to power cord was detached from the bed.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.

• Brand Name: SECURE 3 MED/SURG BEDOBS 01/13
• 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: pravin betala ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 3586732
• MDR Text Key: 4167272
• Report Number: 0001831750-2014-00681
• Device Sequence Number: 1
• Product Code: FNL
• 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: 01/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 3002S3EX
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/07/2014
• 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