MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO UNKNOWN_MEDICAL_PRODUCT; STRETCHER, HAND-CARRIED

Catalog Number UNK_MED

Device Problems Collapse (1099); Device Fell (4014)

Patient Problems Bone Fracture(s) (1870); Laceration(s) (1946); Muscle/Tendon Damage (4532)

Event Date 01/18/2021

Event Type  Injury  

Manufacturer Narrative

The customer did not record the model or serial number at the time of the incident.

Event Description

It was reported that a stair chair was being used to transport a patient by two emts.The customer stated that the emts were in a hurry and failed to properly engage the support tracks on the stair chair.As a result, the chair fell back on the stairs and then pivoted when it reached the bottom, throwing the emt who was behind it over the chair.The emt sustained a fractured humerus, 8 fractured ribs, a torn muscle in his back and a torn artery that required surgery.The patient was not injured as a result of the event.

Manufacturer Narrative

The section h codes have been updated to more accurately reflect the results of the completed investigation.

Event Description

It was reported that a stair chair was being used to transport a patient by two emts.The customer stated that the emts were in a hurry and failed to properly engage the support tracks on the stair chair.As a result, the chair fell back on the stairs and then pivoted when it reached the bottom, throwing the emt who was behind it over the chair.The emt sustained a fractured humerus, 8 fractured ribs, a torn muscle in his back and a torn artery that required surgery.The patient was not injured as a result of the event.

• Brand Name: UNKNOWN_MEDICAL_PRODUCT
• Type of Device: STRETCHER, HAND-CARRIED
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• MDR Report Key: 11392771
• MDR Text Key: 234014078
• Report Number: 0001831750-2021-00658
• Device Sequence Number: 1
• Product Code: FPP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 05/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: UNK_MED
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other