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

Catalog Number UNK_MED

Device Problem Collapse (1099)

Patient Problem Injury (2348)

Event Date 04/08/2016

Event Type  Injury  

Event Description

It was reported that the fowler of a bed collapsed.Allegedly, the patient that was on the bed at this time injured his back as a result.It is unknown what type of bed was in use at the time of the event.The severity of the alleged injury was not reported.

Manufacturer Narrative

This user facility owns multiple types of beds, including beds that are not manufactured by stryker.The hospital has not been able to confirm what type of bed this event occurred on, and the event was never recorded by their staff.User facility could not provide information on unit involved in alleged event.

Event Description

It was reported that the fowler of a bed collapsed.Allegedly, the patient that was on the bed at this time injured his back as a result.It is unknown what type of bed was in use at the time of the event.The severity of the alleged injury was not reported.

• Brand Name: UNKNOWN_MEDICAL_PRODUCT
• 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: mary klaver ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 5724224
• MDR Text Key: 47393311
• Report Number: 0001831750-2016-00195
• 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: 05/23/2016

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?: Yes
• Device Operator: No Information
• Device Catalogue Number: UNK_MED
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/23/2016
• Initial Date FDA Received: 06/14/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/07/2016
• 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