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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2021

Event Type  malfunction  

Manufacturer Narrative

This record is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.1 device was functionally/visually inspected in the field.The device was repaired and returned to use.There was no remedial action taken.This device is not labeled for single use.

Event Description

This report summarizes 1 malfunction event, where it was reported the stirrup unexpectedly fell/collapsed.There was no patient involvement.

Manufacturer Narrative

It was originally reported the stirrup had an unexpected drop/collapse but after further investigation it was determined the stirrup was simply loose/wobbly, which is not reportable.

Event Description

This report summarizes 1 malfunction event, where it was reported the stirrup was loose.There was no patient involvement.

• 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: 11715668
• MDR Text Key: 251947083
• Report Number: 0001831750-2021-00875
• 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): Y
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 04/01/2021
• Initial Date FDA Received: 04/23/2021
• Supplement Dates Manufacturer Received: 04/01/2021
• Supplement Dates FDA Received: 10/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1