6257 XPEDITION HIGH CONFIG
Received Jan 12, 2024 · Event occurred Dec 10, 2023
Report 0001831750-2024-00011 · MDR key 18504959
Device
Generic name
Transport, Patient, Powered
Manufacturer
Stryker Medical-kalamazooCatalog number
625705550002
Product problems
- Unintended System Motion
- Adverse Event Without Identified Device or Use Problem
- Unintended System Motion
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Pain
- Unspecified Musculoskeletal problem
- Pain
- Unspecified Musculoskeletal problem
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE DEVICE WAS USED TO GO DOWN THE FRONT STAIRS OF A SINGLE FAMILY RESIDENCE WHILE IT WAS RAINING. WHEN THE DEVICE HIT THE SECOND STEP, IT STARTED TO SLIP AND LOST TRACTION, SLIDING TO THE THIRD STEP. THE LOSS OF TRACTION CAUSED THE WEIGHT OF THE DEVICE TO TWEAK THE PROVIDER'S BACK AND PULLED HIM DOWN. LATER, THE PROVIDER COMPLAINED THAT HIS BACK REALLY HURT.
Additional Manufacturer Narrative
AS A RESULT OF THE REPORTED EVENT, A STRYKER (B)(6) MADE MULTIPLE ATTEMPTS TO GATHER FURTHER INFORMATION. THESE ATTEMPTS INCLUDED AN EMAIL COMMUNICATION ON JANUARY 18TH, 2024 AND FEBRUARY 1ST, 2024. AS NO RESPONSE WAS RECEIVED, A WRITTEN EMAIL WAS SENT ON MAY 29TH, 2024 REQUESTING THE CUSTOMER TO RESPOND WITH THE REQUESTED INFORMATION. BASED ON THE INFORMATION PROVIDED IN THE EVENT DESCRIPTION, THE STRYKER (B)(6) DETERMINED THAT THE ALLEGED TRACKS DESCENDING TOO FAST WAS LIKELY NOT DUE TO A COMPONENT LEVEL DEFECT BUT DUE TO THE USER LOSING CONTROL ON THE WET STAIRS. MULTIPLE ATTEMPTS HAVE BEEN MADE TO GATHER THE SERIAL NUMBER, FURTHER INFORMATION SURROUNDING THE EVENT, AND THE RESOLUTION, WITH NO RESPONSE RECEIVED. SHOULD A RESPONSE BE RECEIVED, THIS COMPLAINT MAY BE REOPENED AND UPDATED ACCORDINGLY.
Description of Event or Problem
IT WAS REPORTED THAT THE DEVICE WAS USED TO GO DOWN THE FRONT STAIRS OF A SINGLE FAMILY RESIDENCE WHILE IT WAS RAINING. WHEN THE DEVICE HIT THE SECOND STEP, IT STARTED TO SLIP AND LOST TRACTION, SLIDING TO THE THIRD STEP. THE LOSS OF TRACTION CAUSED THE WEIGHT OF THE DEVICE TO TWEAK THE PROVIDER'S BACK AND PULLED HIM DOWN. LATER, THE PROVIDER COMPLAINED THAT HIS BACK REALLY HURT.