MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO 5TH WHEEL STRETCHER, PRIME X; STRETCHER, WHEELED

Model Number	1105
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/26/2022
Type of Reportable Event	Death
Event or Problem Description
It was reported that a patient had allegedly got there head between the side-rails and has since died.The customer has not stated if the trapping of the head was due to a malfunction of the side-rail and has put the stretcher back into use.The customer is also unable to confirm the serial number of the stretcher.
Additional Manufacturer Narrative
The serial number of the unit involved in the incident was not recorded.As a result, the unit could not be inspected, however, the customer was unable to state whether the issue was due to a malfunction with the device and put the unit back into service.Multiple requests, including written, were sent to the account for additional information related to the alleged issue.No additional information was provided by the account.A review of previous similar complaints identified that the issue was likely not due to a defect with the product.H3 other text : device not accessible for evaluation.
Event or Problem Description
It was reported that a patient had allegedly got their head between the side-rails and has since died.The customer has not stated if the trapping of the head was due to a malfunction of the side-rail and has put the stretcher back into use.The customer is also unable to confirm the serial number of the stretcher.

• Brand Name: 5TH WHEEL STRETCHER, PRIME X
• 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: brian thompson ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 13386505
• Report Number: 0001831750-2022-00244
• Device Sequence Number: 4897858
• Product Code: FPO
• UDI-Device Identifier: 07613327278194
• UDI-Public: 07613327278194
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,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?: No
• Device Model Number: 1105
• Device Catalogue Number: 1105000000X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/26/2022
• Supplement Date Received by Manufacturer: 01/26/2022
• Initial Report FDA Received Date: 01/28/2022
• Supplement Report FDA Received Date: 04/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Death
• Patient Sex: Unknown