MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO S3 PX4-3005; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number 3005

Device Problem Peeled/Delaminated (1454)

Patient Problem No Patient Involvement (2645)

Event Date 12/02/2017

Event Type  malfunction  

Manufacturer Narrative

This mdr is part of the malfunction summary reporting program, exemption number e2014007.The device was evaluated in the field and the issue was confirmed.There were no remedial actions taken.This device is not labeled for single use.

Event Description

This report summarizes 1 malfunction event, where it was reported the power cord had exposed wires.No patient was involved.

• Brand Name: S3 PX4-3005
• 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: mary klaver ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 7453574
• MDR Text Key: 106271555
• Report Number: 0001831750-2018-00334
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 07613327278422
• UDI-Public: (01)07613327278422
• 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
• Report Date: 04/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 3005
• Device Catalogue Number: 3005S3PX4
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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