MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO POWER PRO AMBULANCE COT - OBS; STRETCHER, WHEELED

Catalog Number 6500000000

Device Problem Device Tipped Over (2589)

Patient Problem Bone Fracture(s) (1870)

Event Date 06/02/2022

Event Type  Death  

Event Description

I was reported that the cot tipped over when the patient shifted their position.It was reported that the patient broke their leg.Further information has not been provided.

Manufacturer Narrative

It was reported that the patient was approximately 250 lbs and was moving excessively on the cot, causing the cot to tip.It was additionally reported that the patient later passed away.

Event Description

I was reported that the cot tipped over when the patient shifted their position.It was reported that the patient broke their leg.It was additionally reported that the patient later passed away.

• Brand Name: POWER PRO AMBULANCE COT - OBS
• 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: 14859205
• MDR Text Key: 295064801
• Report Number: 0001831750-2022-00602
• Device Sequence Number: 1
• Product Code: FPO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/22/2022

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 Catalogue Number: 6500000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/02/2022
• Initial Date FDA Received: 06/29/2022
• Supplement Dates Manufacturer Received: 06/02/2022
• Supplement Dates FDA Received: 08/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/08/2008
• 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
• Patient Outcome(s): Other; Death