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

Catalog Number 6500000000

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Pain (1994); Injury (2348)

Event Date 10/23/2017

Event Type  malfunction  

Manufacturer Narrative

It was reported that the injured emt had neck pain and upper arm pain which has worsened since the alleged event and they will be going to the doctor for treatment.The patient was not alleged to have been affected as a result of this event.

Event Description

It was alleged that while loading the cot into the ambulance, the 2 emts allegedly lifted the cot off the ground in order to begin raising the legs.When the other emt pressed the minus button, the cot legs allegedly did not start to raise so the other emt allegedly went to push the cot legs against the ground in order to get the movement stated.When the other emt did this the other emt was allegedly unaware, and was still trying to hold the cot and heavy patient up, thus injuring the emt's back.

• 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: brian thompson ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 7042670
• MDR Text Key: 93127638
• Report Number: 0001831750-2017-00524
• 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: 11/17/2017

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: No Information
• Device Catalogue Number: 6500000000
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/23/2017
• Initial Date FDA Received: 11/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2008
• 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