MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO POWER LOAD; STRETCHER, WHEELED

Catalog Number 6390000000

Device Problems Break (1069); Device Fell (4014)

Patient Problems Death (1802); Pain (1994); No Consequences Or Impact To Patient (2199)

Event Date 07/30/2019

Event Type  malfunction  

Event Description

It was alleged that the cot dropped off from the cot fastener when the arms of the cot fastener didn't hold while trying to unload to pick up the patient.It was reported that 2 user's hurt their wrists because they tried to catch the cot when cot fastener arms failed.It was reported that the user's couldn't load the patient and had to call another ambulance.It was reported that the patient died, however it was not reported if the patient death was a result of the events that occurred as further information was not provided.

Manufacturer Narrative

It was reported that the 2 caregivers received minor wrist strains.It was also confirmed that the device did not cause or contribute to the patient's passing.

Event Description

It was alleged that the cot dropped off from the cot fastener when the arms of the cot fastener didn't hold while trying to unload to pick up the patient.It was reported that 2 user's hurt their wrists because they tried to catch the cot when cot fastener arms failed.It was reported that the user's couldn't load the patient and had to call another ambulance.It was reported that the patient died, however it was confirmed that the device did not cause or contribute to the patient's passing.

• Brand Name: POWER LOAD
• 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: 8932335
• MDR Text Key: 155569656
• Report Number: 0001831750-2019-00908
• Device Sequence Number: 1
• Product Code: FPO
• UDI-Device Identifier: 07613327261523
• UDI-Public: 07613327261523
• 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: 11/12/2019

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?: No
• Device Operator: No Information
• Device Catalogue Number: 6390000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/01/2019
• Initial Date FDA Received: 08/26/2019
• Supplement Dates Manufacturer Received: 08/01/2019
• Supplement Dates FDA Received: 11/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/06/2017
• 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
• Treatment: 6506000000,POWER PRO AMBULANCE COT