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

Catalog Number 1115000000X

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Respiratory Distress (2045); Anxiety (2328); No Known Impact Or Consequence To Patient (2692)

Event Date 06/13/2015

Event Type  malfunction  

Event Description

The customer reported that the patient allegedly got their head stuck in the bend of the side rail of the device.The customer further reported that the patient was large, allegedly, had learning difficulties, was agitated and that they wiggled down the stretcher.It was reported that all of these factors contributed to the patient getting into a position where their head was stuck in the side rail.It was reported that the patient appeared to be having difficulty breathing due to the position of the side rail in relation to their neck.It was reported that staff attempted to free the patient's head and had to call on the assistance of the fire brigade.The patient was successfully freed and staff reported that no long term consequences for the patient were expected.

Event Description

The customer reported that the patient allegedly got their head stuck in the bend of the side rail of the device.The customer further reported that the patient was large, allegedly had learning difficulties, was agitated and that they wiggled down the stretcher.It was reported that all of these factors contributed to the patient getting into a position where their head was stuck in the side rail.It was reported that the patient appeared to be having difficulty breathing due to the position of the side rail in relation to their neck.It was reported that staff attempted to free the patient's head and had to call on the assistance of the fire brigade.The patient was successfully freed and staff reported that no long term consequences for the patient were expected.

• Brand Name: BIG WHEEL STRETCHER, PRIME X
• 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: brian thompson ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 4845059
• MDR Text Key: 17936879
• Report Number: 0001831750-2015-00277
• Device Sequence Number: 1
• Product Code: FPO
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/15/2015

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 Operator: Other
• Device Catalogue Number: 1115000000X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/15/2015
• Initial Date FDA Received: 06/15/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/17/2015
• 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