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

Catalog Number 6500000000

Device Problems Difficult or Delayed Positioning (1157); No Apparent Adverse Event (3189)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/17/2021

Event Type  malfunction  

Event Description

It was reported that while unloading the cot, a paramedic received a back injury.The injury is being treated with physical therapy.It was further reported that there was a small delay in transporting the patient to the hospital as a result, but no reports of adverse consequences to the patient.An investigation is being initiated into the alleged event.

Manufacturer Narrative

Upon investigation, it was found that the reported event and injury were previously captured in mfr report # 0001831750-2021-01647.Additionally, it was found that this device (model number 6500, serial number (b)(6)) did not cause or contribute to the alleged event/injury.

Event Description

It was originally reported that while unloading the cot, a paramedic received a back injury.Upon investigation, it was found that this device (model number 6500, serial number (b)(6)) did not cause or contribute to the alleged event/injury.

• 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: melanie shepard ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 12933594
• MDR Text Key: 281742966
• Report Number: 0001831750-2021-01645
• 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: 02/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 6500000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/17/2021
• 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
• Patient Outcome(s): Other