MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO PRIME 5TH WHEEL STRETCHER 26"; STRETCHER, WHEELED

Catalog Number 1105000026

Device Problems Difficult or Delayed Positioning (1157); Mechanical Jam (2983)

Patient Problems Pain (1994); Unspecified Musculoskeletal problem (4535)

Event Date 11/28/2023

Event Type  malfunction  

Event Description

It was reported that the device has stiffness/steering issues.A staff member completed an incident report complaining of back pain, which caused them to take sick leave days.Attempts are being made to gather additional details from the user facility.

Manufacturer Narrative

It was reported by the customer that there was an injury to a staff member as a result of the stretcher being stiff and difficult to steer.It was further reported that the injury the staff member sustained was back pain, which caused them to take time off work.The serial number of the unit in which this event occurred was not documented by the customer at the time of the event.Therefore, two units were evaluated as a sample from the stretchers at the account.A visual and functional inspection was performed by a stryker field service technician.It was identified that there was no component-level defect or malfunction which could have caused or contributed to the start-up resistance/rolling resistance being too great.This issue was resolved for the customer by confirming that there was no component-level defect or malfunction with the sample units evaluated.

Event Description

It was reported that the device has stiffness/steering issues.A staff member completed an incident report complaining of back pain, which caused them to take sick leave days.

• Brand Name: PRIME 5TH WHEEL STRETCHER 26"
• 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: alex wibert ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 18310975
• MDR Text Key: 330285000
• Report Number: 0001831750-2023-01362
• Device Sequence Number: 1
• Product Code: FPO
• UDI-Device Identifier: 07613327278149
• UDI-Public: 07613327278149
• Combination Product (y/n): N
• Reporter Country Code: EI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 1105000026
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2023
• Was Device Evaluated by Manufacturer?: No
• 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