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

Catalog Number 6500000000

Device Problem Device Tipped Over (2589)

Patient Problems Bruise/Contusion (1754); Bone Fracture(s) (1870); Pain (1994)

Event Date 06/29/2020

Event Type  Injury  

Event Description

It was reported that while transporting a (b)(6) patient, the patient shifted their weight while the cot was on the safety hook during unloading which resulted in the cot tipping over and the patient falling off the cot.The ems team was able to catch the patient who sustained no injuries from the event but a member of the ems team sustained an unknown injury.

Manufacturer Narrative

It was initially reported that the injury details were unknown.The user facility has provided details and b5 has been updated with the new information.

Event Description

It was reported that while transporting a 400lb patient, the patient shifted their weight while the cot was on the safety hook during unloading which resulted in the cot tipping over and the patient falling off the cot.The ems team was able to catch the patient who sustained no injuries from the event but a member of the ems team sustained a bruised foot and broken bone in their toe that required treatment.

• 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
• MDR Report Key: 10305556
• MDR Text Key: 199864702
• Report Number: 0001831750-2020-00643
• Device Sequence Number: 1
• Product Code: FPO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 10/07/2020

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?: No
• Device Operator: No Information
• Device Catalogue Number: 6500000000
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/30/2020
• Initial Date FDA Received: 07/21/2020
• Supplement Dates Manufacturer Received: 06/30/2020
• Supplement Dates FDA Received: 10/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other