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

Model Number 6516

Device Problems Difficult or Delayed Positioning (1157); Device Fell (4014)

Patient Problem Insufficient Information (4580)

Event Date 11/23/2021

Event Type  malfunction  

Event Description

It was reported that the cot was dropped during unloading.It was further reported that as a result, a user received an injury that required medical attention.Further details regarding the injury and treatment have not yet been provided.

Event Description

It was reported that the cot was dropped during unloading.It was further reported that as a result, a user hurt their hand and took time off work.The customer stated that the user who hurt their hand was not trained on how to unload the cot.

Manufacturer Narrative

The investigation is complete.Section h codes have been updated to reflect that this is a non-serious injury.

Manufacturer Narrative

For the issue of the cot drop; no defect or malfunction was found upon evaluation.The cot drop resulted in a bent/deformed head section, resulting in difficulty to load/unload the cot.

Event Description

It was reported that the cot dropped, causing the head section to become bent/deformed.A user allegedly hurt their hand as a result, and took time off work.Upon investigation, it was discovered that the user who hurt their hand was untrained on how to unload the cot, and the cot drop was likely caused by user error; no defect or malfunction was found upon evaluation of the device.

• Brand Name: POWER PRO IT 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: melanie shepard ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 12920436
• MDR Text Key: 281667281
• Report Number: 0001831750-2021-01643
• Device Sequence Number: 1
• Product Code: FPO
• UDI-Device Identifier: 07613327261578
• UDI-Public: 07613327261578
• 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: 04/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 6516
• Device Catalogue Number: 6516000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/29/2021
• 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
• Patient Outcome(s): Other