MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO UNKNOWN_MEDICAL_PRODUCT; STRETCHER, WHEELED

Catalog Number UNK_MED

Device Problems Mechanical Problem (1384); Vibration (1674)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/13/2023

Event Type  malfunction  

Event Description

It was reported that the wheels do not lock securely.There was patient involvement, but no serious injuries, adverse consequences, or clinically relevant delays in treatment were reported.

Event Description

It was reported that the caster tires were broken off the device.There was patient involvement, but no serious injuries, adverse consequences, or clinically relevant delays in treatment were reported.

Manufacturer Narrative

The catalog number, serial number, and manufacturing date were updated.The device was evaluated, and section h codes have been updated.

• Brand Name: UNKNOWN_MEDICAL_PRODUCT
• Type of Device: STRETCHER, WHEELED
• 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: alex wibert ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 16709598
• MDR Text Key: 312986272
• Report Number: 0001831750-2023-00332
• Device Sequence Number: 1
• Product Code: FPO
• 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: 07/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: UNK_MED
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2004
• 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