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

Catalog Number UNK_MED

Device Problems Positioning Failure (1158); Device Fell (4014)

Patient Problems Headache (1880); Pain (1994); Insufficient Information (4580)

Event Date 03/25/2023

Event Type  malfunction  

Event Description

It was reported that the device was raised, which allows the patient to eat, and allegedly malfunctioned by collapsing down on the nurse.As a result, the nurse hit head, resulting in a constant headache with muscle spasms in the neck and shoulder.Attempts are being made to gather additional details from the user facility.

Manufacturer Narrative

A stryker quality engineer also talked to the biomed department at the account who explained that the fowler fasteners had backed out, causing the head of the bed to fall.They had reinstalled the fasteners, which repaired the bed.It was determined the cause of the fowler collapse that resulted in a patient injury was the fowler fasteners being missing.The quality assurance engineer also spoke with the patient who explained that she had a migraine, blurry vision, and neck and shoulder pain.She received pain medication at the hospital for these symptoms.Stephanie spoke with risk management at the facility who stated that the patient had these symptoms before the head of the bed collapsed.

Event Description

It was reported that the device's fowler was raised and allegedly malfunctioned by collapsing.The patient complained of a migraine, blurry vision, and neck and shoulder pain.

• 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: marleca lane ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 16846811
• MDR Text Key: 314319646
• Report Number: 0001831750-2023-00640
• 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: 07/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: UNK_MED
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/03/2023
• 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
• Patient Outcome(s): Other