MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO POWER-PRO TL COT; STRETCHER, WHEELED

Catalog Number 6550000000

Device Problem Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Date 10/01/2018

Event Type  malfunction  

Manufacturer Narrative

This mdr is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.The devices were evaluated in the field and the issue was confirmed.However, there was no product malfunction.There was no remedial action taken.This device is not labeled for single use.

Event Description

This report summarizes 4 malfunction event, where it was reported the restraints were missing.There was no patient involvement.

• Brand Name: POWER-PRO TL COT
• Type of Device: STRETCHER, WHEELED
• 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: 8283533
• MDR Text Key: 134327023
• Report Number: 0001831750-2019-00255
• Device Sequence Number: 1
• Product Code: FPO
• UDI-Device Identifier: 07613327261660
• UDI-Public: 07613327261660
• 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
• Report Date: 01/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 6550000000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/01/2019
• 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