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

Catalog Number 6506000000

Device Problems Component Falling (1105); Unintended System Motion (1430); Device Tipped Over (2589)

Patient Problems Fall (1848); Injury (2348)

Event Date 09/29/2017

Event Type  Injury  

Manufacturer Narrative

Device not returned.

Event Description

It was reported that a (b)(6) quadriplegic patient was being unloaded by two emts.As they were unloading the patient, the crew noticed that the cot battery was dead, and not working.The decision was made to unload the patient in manual mode.The crew used the foot end, head end operator configuration.After verifying the cot safety bar was engaged with the safety hook, the foot end operator used the manual release handle to lower the cots legs.Once the legs touched the ground, the head end operator reached around and pulled the safety bar release handle so the bar raised up and over the safety hook.It was as this was happening, that the crew noticed the undercarriage of the cot was dropping.The load wheels of the cot fell out of the patient compartment, down onto the bumper, and the cot started to tilt sideways, to the patient's right.The crew could not catch the patient.It was reported that the patient fell, and hit the ground, receiving serious injuries that were not disclosed at the time of reporting.The patient was reported as requiring hospitalization as a result of the drop.The customer alleged that both chest harness straps, lap strap, and upper leg strap were in use at the time of the incident.

• Brand Name: POWER PRO AMBULANCE COT
• 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: 6988722
• MDR Text Key: 90627133
• Report Number: 0001831750-2017-00477
• 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
• Report Date: 10/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 6506000000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/02/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/24/2015
• 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