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

Catalog Number 3002S3EX

Device Problem Insufficient Information (3190)

Patient Problems Fall (1848); Injury (2348)

Event Date 12/14/2017

Event Type  Injury  

Event Description

It was reported that the patient fell out of the bed receiving unknown injuries that required them to go to the icu.No further information regarding the patient condition was given at this time.

Manufacturer Narrative

The issue was resolved for the customer by performing repairs.No further information was given regarding the patient's injuries and any medical intervention required.

Event Description

It was reported that the patient fell out of the bed receiving unknown injuries that required them to go to the icu.No further information regarding the patient condition was given at this time.

• 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: chanda burghard ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 7179463
• MDR Text Key: 96876953
• Report Number: 0001831750-2018-00028
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/16/2018

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: 3002S3EX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/14/2017
• Initial Date FDA Received: 01/10/2018
• Supplement Dates Manufacturer Received: 12/14/2017
• Supplement Dates FDA Received: 03/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2011
• 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