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

Model Number 6506

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Crushing Injury (1797); Laceration(s) (1946)

Event Date 11/18/2021

Event Type  Injury  

Event Description

It was reported that while manually unloading a patient from the ambulance one of the paramedics got her finger caught between the safety bar and the cot.When the cot was released and moved out of the fastener it caused the paramedic's finger to become amputated.

Event Description

It was reported that while manually unloading a patient from the ambulance one of the paramedics got her finger caught between the safety bar and the cot.When the cot was released and moved out of the fastener it cut the tip of the paramedic's finger off.The paramedic needed stitches.The user facility stated that this event was the result of worn components and user error.

Manufacturer Narrative

The investigation has been completed and section h codes have been updated.It was initially reported that the paramedic's finger was amputated due to a crushing injury; however, the user facility followed up and stated that the tip of the finger was lacerated off and repaired with stitches.B5 and clinical codes have been updated.H3 other text : user facility stated there was no further action needed.

Manufacturer Narrative

Upon further investigation it was identified that this event was the result of user error and there was no defect or malfunction related to the pinch/crush point.

Event Description

It was reported that while manually unloading a patient from the ambulance one of the paramedics got her finger caught between the safety bar and the cot.When the cot was released and moved out of the fastener it cut the tip of the paramedic's finger off.The paramedic needed stitches.The user facility stated that this event was the result of user error.

• Brand Name: POWER PRO AMBULANCE COT
• 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: kelsey barla ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 13045570
• MDR Text Key: 283409190
• Report Number: 0001831750-2021-01655
• Device Sequence Number: 1
• Product Code: FPO
• UDI-Device Identifier: 07613327261639
• UDI-Public: 07613327261639
• 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,Followup
• Report Date: 01/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 6506
• Device Catalogue Number: 6506000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/30/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/29/2009
• 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
• Patient Outcome(s): Other; Disability