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

Catalog Number UNK_MED

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Asphyxia (1851)

Event Date 01/01/2015

Event Type  Death  

Event Description

It was reported that a nurse went to the patient room to check on the patient.The patient was allegedly found deceased, kneeling on the floor, with his head between the left headend and footend siderails.The user facility further reported that the patient, who was admitted for "behavioral issues", was ambulatory and was given the freedom to get out of bed and walk around.The unit involved in the reported incident was evaluated by the manufacturer, and no malfunction of defects were found.

Manufacturer Narrative

Stryker medical is submitting this report as the initial importer for this family of products.The manufacturer (chg hospital beds, inc) submitted medwatch 3006433555-2015-00001 related to this incident as well.The product involved is a spirit select hospital bed, with serial number (b)(4).The information in this report was provided to stryker by chg.Please refer to medwatch 3006433555-2015-00001 for additional information.

• 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: 4485085
• MDR Text Key: 20127741
• Report Number: 0001831750-2015-00054
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 02/04/2015,01/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: UNK_MED
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/04/2015
• Distributor Facility Aware Date: 01/05/2015
• Device Age: 8 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/04/2015
• Date Manufacturer Received: 01/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Death
• Patient Age: 67 YR
• Patient Weight: 75