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

Catalog Number 3002 EX

Device Problems Crack (1135); Device Inoperable (1663)

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

Event Date 01/03/2014

Event Type  malfunction  

Event Description

It was reported via repair work order that the fowler was cracked and the foot section was not working.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.

Event Description

It was reported via repair work order that the fowler was cracked and the foot section was not working.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.

Manufacturer Narrative

It was reported that the fowler was cracked and the foot section was not working.After further investigation customer identified that the repair was not needed for the fowler weldment and it was functional.Supplemental submitted as further investigation determined that the foot assembly was not rising correctly due to a damaged gatch weldment.Additionally, it is not likely to harm the patient as gatch is a customer comfort issue only.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.This issue is not likely to cause or contribute to serious injury or death if it was to recur.Visual and functional inspection was allegedly performed by an unidentified individual of truman medical center.

• Brand Name: SECURE II 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: pravin betala ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 3594711
• MDR Text Key: 4000045
• Report Number: 0001831750-2014-00803
• 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,Followup
• Report Date: 01/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 3002 EX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/09/2014
• Initial Date FDA Received: 01/28/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/17/2014
• Was Device Evaluated by Manufacturer?: No
• 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