MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO LD304 MATERNITY BED; TABLE, OBSTETRICAL, AC-POWERED (AND ACCESSORIES)

Model Number 4701

Device Problem Device Fell (4014)

Patient Problem Insufficient Information (4580)

Event Date 03/03/2023

Event Type  Injury  

Event Description

It was reported that, while lowering the device, a surgeon stool was in the way.As the nurse tried to move the stool, the device slammed down on nurse's arm.She went to the emergency room for a potentially broken arm.Attempts are being made to gather additional injury and treatment details from the user facility.

Event Description

It was reported that, while lowering the device, a surgeon stool was in the way.As the nurse tried to move the stool, the device slammed down on nurse's arm.She went to the emergency room for a potentially broken arm.

Manufacturer Narrative

The unit was evaluated by a stryker field service technician, and he confirmed that there was no defect with the unit.It was determined that the unexpected drop/collapse that caused a caregiver injury was not due to any component level defect or malfunction.The nurse was evaluated for a broken arm, after the device allegedly collapsed on her arm.A stryker quality assurance engineer spoke with the stryker field service technician who performed the evaluation, but he did not have any further information on the injury.Multiple attempts, including a written letter, were made to get further information on the injury, but was unsuccessful.If more information becomes available, this investigation may be reopened and updated.

• Brand Name: LD304 MATERNITY BED
• Type of Device: TABLE, OBSTETRICAL, AC-POWERED (AND ACCESSORIES)
• 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: 16657568
• MDR Text Key: 312451794
• Report Number: 0001831750-2023-00327
• Device Sequence Number: 1
• Product Code: HDD
• UDI-Device Identifier: 07613327278095
• UDI-Public: 07613327278095
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K950889
• 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: 05/25/2023

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 Model Number: 4701
• Device Catalogue Number: 4701000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/03/2023
• Initial Date FDA Received: 03/31/2023
• Supplement Dates Manufacturer Received: 03/03/2023
• Supplement Dates FDA Received: 05/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2020
• 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