MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO BED INTOUCH WITH ZOOM MOTOR; BED, AC-POWERED ADJUSTABLE HOSPITAL

Catalog Number 2141000000

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Intermittent Loss of Power (4016)

Patient Problem Insufficient Information (4580)

Event Date 07/13/2023

Event Type  malfunction  

Event Description

It was reported that the device lost power when transporting a patient.The nurse then placed the device in neutral and injured themselves while moving the device.

Manufacturer Narrative

Multiple attempts have been made to gather additional information on the caregiver injury with no response received.

Event Description

It was reported that the device lost power when transporting a patient.The nurse then placed the device in neutral and injured themselves while moving the device.Multiple attempts have been made to gather additional information on the caregiver injury with no response received.

• Brand Name: BED INTOUCH WITH ZOOM MOTOR
• 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: melissa simon ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 17482242
• MDR Text Key: 320760279
• Report Number: 0001831750-2023-00976
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 07613327169232
• UDI-Public: 07613327169232
• 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: 10/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 2141000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2019
• 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