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

Catalog Number 6390000000

Device Problems Break (1069); Sticking (1597)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/10/2014

Event Type  malfunction  

Event Description

It was reported that the power load system will not release the cot and the cot was stuck in the ambulance due to a broken anchor trigger,anchor plunger, and anchor pawl assembly.No patient was affected and no adverse consequence were 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: anthony noora ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 3730277
• MDR Text Key: 4309982
• Report Number: 0001831750-2014-02857
• Device Sequence Number: 1
• Product Code: FPO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 6390000000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/10/2014
• 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