MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO POWER LOAD; STRETCHER, WHEELED

Catalog Number 6390000000

Device Problems Break (1069); Component Incompatible (1108); Fracture (1260); Installation-Related Problem (2965)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 01/10/2019

Event Type  malfunction  

Event Description

It was reported that a power-load had a broken floor plate attachment bracket and there was also incorrect hardware installed in the product.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.

Manufacturer Narrative

The issue was resolved for the customer by communicating to the customer and installer the concerns regarding the incorrect hardware used to install the device and replacing the floor plate attachment bracket.

Event Description

It was reported that a power-load had a broken floor plate attachment bracket and there was also incorrect hardware installed in the product.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.

• Brand Name: POWER LOAD
• 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: brian thompson ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 8314676
• MDR Text Key: 135700534
• Report Number: 0001831750-2019-00266
• Device Sequence Number: 1
• Product Code: FPO
• UDI-Device Identifier: 07613327261523
• UDI-Public: 07613327261523
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 12/03/2019

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 Operator: No Information
• Device Catalogue Number: 6390000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/10/2019
• Initial Date FDA Received: 02/07/2019
• Supplement Dates Manufacturer Received: 01/10/2019
• Supplement Dates FDA Received: 12/03/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/11/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-1389-2018
• Patient Sequence Number: 1