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

Model Number 4701

Device Problem Positioning Failure (1158)

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

Event Date 11/06/2020

Event Type  malfunction  

Event Description

It was reported that during childbirth the stirrup could not be used.The nurse supported the patient's leg during the delivery and injured their shoulder.The treatment and severity of the injury are unknown at this time and the nurse is on leave through worker's compensation.Attempts have been made to reach the customer for more information.

Manufacturer Narrative

The device evaluation has been completed and section h codes have been updated.It was previously reported that the severity and treatment of the injury was unknown; however, more details have been provided by the user facility.Section b5 has been updated.

Event Description

It was reported that during childbirth the stirrup could not be used.The nurse supported the patient's leg during the delivery and injured their shoulder.The user facility did not know the severity of the injury and did not report that it required treatment.The nurse is on leave through worker's compensation.

• 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
• MDR Report Key: 10952081
• MDR Text Key: 219863305
• Report Number: 0001831750-2020-01216
• Device Sequence Number: 1
• Product Code: HDD
• UDI-Device Identifier: 07613327278095
• UDI-Public: 07613327278095
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 02/19/2021

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 Operator: No Information
• Device Model Number: 4701
• Device Catalogue Number: 4701000000
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/06/2020
• Initial Date FDA Received: 12/05/2020
• Supplement Dates Manufacturer Received: 11/06/2020
• Supplement Dates FDA Received: 02/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other