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

Model Number 6506

Device Problems Difficult or Delayed Positioning (1157); Device Fell (4014)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/01/2021

Event Type  malfunction  

Manufacturer Narrative

This record is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.1 device was functionally/visually inspected in the field.For the issue of cot drop, no defect or malfunction was found.For the issue of difficulty loading/unloading the cot into the ambulance, the issue was confirmed.The device was repaired and returned to use.There was no remedial action taken.This device is not labeled for single use.

Event Description

This report summarizes 1 malfunction event in which the device was concurrently experiencing 2 issues: difficulty loading/unloading the cot in the ambulance and a cot drop.There was patient involvement; no adverse consequences were reported.

• 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: melanie shepard ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 12696901
• MDR Text Key: 278360655
• Report Number: 0001831750-2021-01551
• Device Sequence Number: 1
• Product Code: FPO
• UDI-Device Identifier: 07613327261639
• UDI-Public: 07613327261639
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 6506
• Device Catalogue Number: 6506000000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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