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

Catalog Number 4701000000

Device Problems Use of Device Problem (1670); Positioning Problem (3009)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 11/13/2017

Event Type  malfunction  

Event Description

It was reported that the nurse was unable to close the patient left abduction assembly and as she came back around the left side of the bed she hit the patient left calf support and hyperextended her knee.As a result the nurse got an mri, a cortisone shot, and phyiscal therapy.Upon evaluation of the customer's maternity beds, no defects could be found.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.

Manufacturer Narrative

Supplemental submitted to include udi.

Event Description

It was reported that the nurse was unable to close the patient left abduction assembly and as she came back around the left side of the bed she hit the patient left calf support and hyperextended her knee.As a result the nurse got an mri, a cortisone shot, and physical therapy.Upon evaluation of the customer's maternity beds, no defects could be found.No patient was affected and 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: kristen canter ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 7104983
• MDR Text Key: 94643038
• Report Number: 0001831750-2017-00553
• Device Sequence Number: 1
• Product Code: HDD
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 03/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 4701000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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