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

Catalog Number 6500000000

Device Problem Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Date 04/14/2014

Event Type  Injury  

Event Description

It was reported by the customer that they allegedly dropped a patient by missing a safety hook.The customer reported that the ambulance was parked on a grade at the hospital with a patient on the cot and as they came out of the back of the truck, the wheels swiveled and they missed the hook.There was patient involvement; however, no adverse consequence or clinically relevant delay in treatment was reported.

Event Description

It was reported by the customer that they allegedly dropped a patient by missing a safety hook.The customer reported that the ambulance was parked on a grade at the hospital with a patient on the cot and as they came out of the back of the truck, the wheels swiveled and they missed the hook.The patient received scrapes that required medical intervention from the event.

Manufacturer Narrative

A visual and functional inspection was performed by a stryker field service representative.It was alleged that the cot missed the safety bar and dropped out of the ambulance with a patient.It was further reported that the ambulance was parked on an incline (left to right) which caused the cot and the patient to tip onto one load wheel high enough for the safety bar to miss the hook.The patient received scrapes that required medical intervention from the event.In addition, it was reported that there was only one user at the foot end during the unloading procedure.Upon evaluation, the field technician was unable to duplicate the alleged event and found no defects with the device.The issue was resolved for the customer by instructing the customer on how to properly unload the cot.

• Brand Name: POWER PRO AMBULANCE COT - OBS
• 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: 3821328
• MDR Text Key: 4398660
• Report Number: 0001831750-2014-02992
• 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,Followup
• Report Date: 04/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 6500000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/23/2014
• Initial Date FDA Received: 05/20/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/04/2014
• 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