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

Catalog Number 1025000000

Device Problem Mechanical Jam (2983)

Patient Problem No Patient Involvement (2645)

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

This mdr is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.4 devices were evaluated in the field and the issue was confirmed; 2 devices had worn components, 1 device had a broken/damaged component, and 1 device had an alignment issue.The devices were repaired and returned.1 device is pending evaluation.There was no remedial action taken.This device is not labeled for single use.

Event Description

This report summarizes 5 malfunction events, where it was reported the brakes/steer were difficult to engage/disengage or the brakes would not engage.There was no patient involvement.

Manufacturer Narrative

The final device was evaluated and the issue was confirmed.The device had broken/damaged components.The device was repaired and returned to service.

Event Description

This report summarizes 5 malfunction events, where it was reported the brakes/steer were difficult to engage/disengage or the brakes would not engage.There was no patient involvement.

• 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
• MDR Report Key: 10000248
• MDR Text Key: 189088975
• Report Number: 0001831750-2020-00323
• Device Sequence Number: 1
• Product Code: INK
• Combination Product (y/n): N
• Number of Events Reported: 5
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 07/09/2020

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 Operator: No Information
• Device Catalogue Number: 1025000000
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/01/2020
• Initial Date FDA Received: 04/27/2020
• Supplement Dates Manufacturer Received: 04/01/2020
• Supplement Dates FDA Received: 07/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1