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

Catalog Number 4701000000

Device Problems Mechanical Problem (1384); Unintended System Motion (1430)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/11/2018

Event Type  malfunction  

Event Description

It was reported that while a patient was sitting on the labor and delivery bed, the bolt that attaches the foot crank weldment on the patient left side came out, causing the bed to unexpectedly lower.No adverse consequence or clinically relevant delay in treatment was reported.

Manufacturer Narrative

In addition to the missing bolt, the technician found the bushing was worn, affecting the base pivot spacer, bushing, cap screw, and bearing.

Event Description

It was reported that while a patient was sitting on the labor and delivery bed, the bolt that attaches the foot crank weldment on the patient left side came out, causing the bed to unexpectedly lower.No adverse consequence or clinically relevant delay in treatment was reported.

• 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: mary klaver ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 7238806
• MDR Text Key: 99002001
• Report Number: 0001831750-2018-00071
• Device Sequence Number: 1
• Product Code: HDD
• 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: 02/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 4701000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2011
• 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