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

Model Number 3009PX-LEX-400

Device Problems Unintended System Motion (1430); Device Fell (4014)

Patient Problem Pain (1994)

Event Date 01/01/2022

Event Type  malfunction  

Manufacturer Narrative

This record is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.1 device is pending evaluation.There was no remedial action taken.This device is not labeled for single use.

Event Description

This report summarizes 1 malfunction event, where it was reported the device experienced a fowler collapse.There was 1 event with patient involvement; the patient experienced pain.

Event Description

This report summarizes 1 malfunction event, where it was reported the device experienced un-commanded motion.There was 1 event with patient involvement; the patient experienced pain.

Manufacturer Narrative

Upon evaluation of the final device, it was determined the device was experiencing un-commanded motion.The device was repaired and returned to use.

• Brand Name: PROCUITY LEX WITH ISOTOUR STD
• 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: melanie shepard ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 14209510
• MDR Text Key: 290172651
• Report Number: 0001831750-2022-00537
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 07613327541229
• UDI-Public: 07613327541229
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 3009PX-LEX-400
• Device Catalogue Number: 3009PX-LEX-400
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/01/2022
• Was Device Evaluated by Manufacturer?: No
• 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