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

Catalog Number 4701000000

Device Problems Break (1069); Connection Problem (2900)

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

Event Date 07/21/2015

Event Type  malfunction  

Event Description

It was reported via work order that the foot section would not latch due to a damaged mount.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: mary klaver ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 5015903
• MDR Text Key: 24576812
• Report Number: 0001831750-2015-00403
• 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
• Report Date: 07/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2015
• 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
• Date Manufacturer Received: 07/21/2015
• 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