MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO PROCUITY LE WITH ISOTOUR PREM; BED, AC-POWERED ADJUSTABLE HOSPITAL

Catalog Number 3009PX-LE-450

Device Problem Mechanical Problem (1384)

Patient Problems Fall (1848); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/01/2023

Event Type  malfunction  

Manufacturer Narrative

This record is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.2 devices are pending evaluation.There was no remedial action taken.This device is not labeled for single use.

Event Description

This report summarizes 2 malfunction events, where it was reported the devices experienced reduced/inadequate brake force.There was 1 event with patient involvement; no adverse consequences were reported.

Event Description

This report summarizes 2 malfunction events, where it was reported the devices experienced reduced/inadequate brake force.There was 1 event with patient involvement; no adverse consequences were reported.

Manufacturer Narrative

The 1 pending device was not evaluated, as the issue was identified and resolved through communication/interviews with the user facility; no defect or malfunction was found and was due to the user.

• Brand Name: PROCUITY LE WITH ISOTOUR PREM
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• 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: 18566251
• MDR Text Key: 333511417
• Report Number: 0001831750-2024-00173
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 07613327541175
• UDI-Public: 07613327541175
• 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,Followup
• Report Date: 03/26/2024

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: 3009PX-LE-450
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/01/2024
• Initial Date FDA Received: 01/23/2024
• Supplement Dates Manufacturer Received: 01/01/2024
• Supplement Dates FDA Received: 03/26/2024
• 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