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

Catalog Number 3009PX-LEX-400

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Date 01/01/2024

Event Type  malfunction  

Manufacturer Narrative

This record is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.5 devices were functionally/visually inspected in the field.The devices were repaired and returned to use.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 devices experienced accessible ac current.There was no patient involvement.

Event Description

This report summarizes 4 malfunction events, where it was reported the devices experienced accessible ac current.There was no patient involvement.

Manufacturer Narrative

It was originally reported that the device had exposed bare wires reported.This was created in error, as this work order may have been confused with another one for the same device.The issue identified with this device is not reportable.Because of this, the number of reported events has been changed from 5 to 4.

• 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: melissa simon ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 19159437
• MDR Text Key: 341180091
• Report Number: 0001831750-2024-00540
• 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: 4
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 3009PX-LEX-400
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/01/2024
• 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