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

Catalog Number 4701-000-000

Device Problem Mechanical Problem (1384)

Patient Problem Insufficient Information (4580)

Event Date 08/13/2021

Event Type  malfunction  

Event Description

Two doctors were present.Patient arrived ready to deliver and physicians called for bed to be broken down for delivery.Unable to break down bed due to malfunctioning equipment.Feet of bed were lowered for mds to be able to emergently apply a kiwi vacuum for fetal heart rate deceleration.Newborn delivered via vacuum assistance with apgar's.

• Brand Name: LD304 BIRTHING BED
• Type of Device: TABLE, OBSTETRICAL, AC-POWERED (AND ACCESSORIES)
• Manufacturer (Section D): STRYKER MEDICAL; 3800 east centre avenue; portage MI 49002
• MDR Report Key: 12438214
• MDR Text Key: 270283010
• Report Number: 12438214
• Device Sequence Number: 1
• Product Code: HDD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 4701-000-000
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/31/2021
• Date Report to Manufacturer: 09/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 13140 DA