MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO STAIR PRO - MODEL 6252; STRETCHER, HAND-CARRIED

Catalog Number 6252000000

Device Problem Difficult or Delayed Positioning (1157)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/01/2023

Event Type  malfunction  

Event Description

This report summarizes 92 malfunction events, where it was reported the devices experienced difficult to maneuver (no tip).There were 2 events with patient involvement; no adverse consequences were reported.

Manufacturer Narrative

This record is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.86 devices were functionally/visually inspected in the field.The devices were repaired and returned to use.1 device was not evaluated and no cause was determined, as the customer did not make the device accessible for testing.5 devices are pending evaluation.There was no remedial action taken.This device is not labeled for single use.

Manufacturer Narrative

One device that was pending was evaluated in the field and the issue was confirmed as well as another issue was found.The record is being removed from this record and being created under a separate mdr.Because of this, the number of reported events has been changed from 92 to 91.

Event Description

This report summarizes 91 malfunction events, where it was reported the devices experienced difficult to maneuver (no tip).There was 1 event with patient involvement; no adverse consequences were reported.

Event Description

This report summarizes 92 malfunction events, where it was reported the devices experienced difficult to maneuver (no tip).There were 2 events with patient involvement; no adverse consequences were reported and insufficient information provided.

Manufacturer Narrative

Updated a health code.

Event Description

This report summarizes 92 malfunction events, where it was reported the devices experienced difficult to maneuver (no tip).There was 1 event with patient involvement; no adverse consequences were reported.

Manufacturer Narrative

The number of events has been updated to include an event previously reported on mfr report # 0001831750-2023-01293 following the completion of an investigation.1 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.1 device pending evaluation was evaluated in the field and the issue was confirmed.The device was repaired on site and returned to service.Section h codes have been updated to reflect this.2 devices are still pending evaluation.

• Brand Name: STAIR PRO - MODEL 6252
• Type of Device: STRETCHER, HAND-CARRIED
• 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: brandon luckas ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 17997585
• MDR Text Key: 326464984
• Report Number: 0001831750-2023-01192
• Device Sequence Number: 1
• Product Code: FPP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 92
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 6252000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/01/2023
• 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