MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO S3 EX - 3005; BED, AC-POWERED ADJUSTABLE HOSPITAL

Catalog Number 3005S3EX

Device Problem Insufficient Information (3190)

Patient Problems Fall (1848); Injury (2348)

Event Date 06/21/2018

Event Type  malfunction  

Event Description

It was reported that the patient fell out of bed and was injured.No details were given regarding the type of injury or any possible medical intervention.

Manufacturer Narrative

A visual and functional inspection was performed by a field service representative.No component level defect was found with the unit and the failure could not be replicated.This issue was resolved for the customer by testing functionality of the unit and returning it to use.The patient suffered light bruising of the knee as a result of the event.It was confirmed that no medical intervention was required and that the patient did not require any additional medical treatment as a result of the injury.

Event Description

It was reported that the patient fell out of bed and was injured.

• Brand Name: S3 EX - 3005
• 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: brian thompson ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 7700745
• MDR Text Key: 114679032
• Report Number: 0001831750-2018-00775
• 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: 08/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 3005S3EX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/21/2018
• Initial Date FDA Received: 07/18/2018
• Supplement Dates Manufacturer Received: 06/21/2018
• Supplement Dates FDA Received: 08/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2018
• 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