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

Model Number	6516
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Device Fell (4014)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/23/2021
Type of Reportable Event	Malfunction
Event or Problem 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 or Problem 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.
Additional Manufacturer Narrative
The investigation is complete.Section h codes have been updated to reflect that this is a non-serious injury.
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 0001831750-2021-01643
• Device Sequence Number: 12080083
• Product Code: FPO
• UDI-Device Identifier: 07613327261578
• UDI-Public: 07613327261578
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/29/2022

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 Model Number: 6516
• Device Catalogue Number: 6516000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/29/2021
• Supplement Date Received by Manufacturer: 11/29/2021; 11/29/2021
• Initial Report FDA Received Date: 12/02/2021
• Supplement Report FDA Received Date: 01/26/2022; 04/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown