MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO SM304 M-SERIES W/ZOOM; STRETCHER, WHEELED, POWERED

Catalog Number 1025000000

Device Problems Break (1069); Device Slipped (1584)

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

Event Date 03/04/2014

Event Type  malfunction  

Event Description

It was reported via repair work order that the right siderail would not latch upright due to a damaged latch spindle.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.

• Brand Name: SM304 M-SERIES W/ZOOM
• Type of Device: STRETCHER, WHEELED, POWERED
• 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: anthony noora ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 3714673
• MDR Text Key: 4250166
• Report Number: 0001831750-2014-02812
• Device Sequence Number: 1
• Product Code: INK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022309
• 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: 03/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 1025000000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/04/2014
• 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