MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO UNKNOWN_MEDICAL_PRODUCT; BED, FLOTATION THERAPY, POWERED

Catalog Number UNK_MED

Device Problem Insufficient Information (3190)

Patient Problem Fall (1848)

Event Date 02/27/2018

Event Type  malfunction  

Event Description

It was reported that the patient was sitting on the edge of the unit and slid off.There was patient involvement, however no adverse consequence or clinically relevant delay in treatment was reported.

Manufacturer Narrative

During the course of the investigation it was found that the mattress is not manufactured or distributed by stryker.Device not manufactured by stryker.

Event Description

It was reported that the patient was sitting on the edge of the unit and slid off.There was patient involvement, however no adverse consequence or clinically relevant delay in treatment was reported.

• Brand Name: UNKNOWN_MEDICAL_PRODUCT
• Type of Device: BED, FLOTATION THERAPY, POWERED
• 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: 7430868
• MDR Text Key: 105670280
• Report Number: 0001831750-2018-00200
• Device Sequence Number: 1
• Product Code: IOQ
• 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: 05/21/2018

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: No Information
• Device Catalogue Number: UNK_MED
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/16/2018
• Initial Date FDA Received: 04/13/2018
• Supplement Dates Manufacturer Received: 03/16/2018
• Supplement Dates FDA Received: 05/21/2018
• 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