MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO M-1 COT - BASE HIGH LOAD 28; STRETCHER, WHEELED

Catalog Number 6100003000

Device Problem Device Fell (4014)

Patient Problem Bone Fracture(s) (1870)

Event Date 05/07/2019

Event Type  malfunction  

Manufacturer Narrative

It was reported that the patient had terminal cancer and had a fractured vertebra.It was not reported which vertebra was effected.It is not known if the cot dropping resulted in the fractured vertebra.It was reported that the patient did die, however the patient did not die as a result of or immediately after the event.It was reported that further information will not be provided regarding this event.

Event Description

It was reported that the cot dropped down while transporting a patient.It was reported that the patient had fractured vertebra.It is not known if the cot dropping resulted in the fractured vertebra.

• Brand Name: M-1 COT - BASE HIGH LOAD 28
• 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: 8621368
• MDR Text Key: 145490783
• Report Number: 0001831750-2019-00567
• Device Sequence Number: 1
• Product Code: FPO
• UDI-Device Identifier: 07613327261530
• UDI-Public: 07613327261530
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/17/2019

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?: Yes
• Device Operator: No Information
• Device Catalogue Number: 6100003000
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/14/2019
• Initial Date FDA Received: 05/17/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/16/2008
• 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