MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO SM204 M-SERIES W/BIG WHEEL; STRETCHER, WHEELED

Catalog Number 1015000000

Device Problem Positioning Failure (1158)

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

Event Date 01/01/2024

Event Type  malfunction  

Event Description

This report summarizes 2 malfunction events, where it was reported the device experienced false latch of siderail.There was no patient involvement.

Manufacturer Narrative

This record is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.1 device was not evaluated and no cause was determined, as the customer did not make the device accessible for testing.1 device is pending evaluation.There was no remedial action taken.This device is not labeled for single use.

Manufacturer Narrative

The device that was pending evaluation was not made available by the customer; the reported issue was not confirmed.Section h codes have been updated to reflect this.

Event Description

This report summarizes 2 malfunction events, where it was reported the device experienced false latch of siderail.There was no patient involvement.

• Brand Name: SM204 M-SERIES W/BIG WHEEL
• 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: melissa simon ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 19155801
• MDR Text Key: 341517465
• Report Number: 0001831750-2024-00457
• Device Sequence Number: 1
• Product Code: FPO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 2
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 1015000000
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/01/2024
• Initial Date FDA Received: 04/22/2024
• 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