MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO ADEL OBS 6/04; TABLE, OBSTETRICAL, AC-POWERED (AND ACCESSORIES)

Catalog Number 4700000000

Device Problems Device Slipped (1584); Naturally Worn (2988)

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

Event Date 09/19/2014

Event Type  malfunction  

Event Description

It was reported via repair work order that the foot section could not be locked in place due to a worn latch.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.

• Brand Name: ADEL OBS 6/04
• 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: 4129867
• MDR Text Key: 4918335
• Report Number: 0001831750-2014-03284
• 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
• Report Date: 09/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 4700000000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/19/2014
• 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