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

Catalog Number 6390000000

Device Problem Difficult to Remove (1528)

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

Event Date 10/05/2021

Event Type  malfunction  

Manufacturer Narrative

User facility canceled their request for service.

Event Description

It was reported that the cot got stuck in the ambulance while trying to unload a patient.There were no reported adverse consequences.The customer canceled their request for service before providing further details, including a model or serial number.The customer stated no further action is needed from stryker.

Manufacturer Narrative

The investigation is complete and section h codes and product information under section d have been updated to reflect this.Upon evaluation by a stryker field service technician it was found that the customer was experiencing a non-reportable issue.

Event Description

It was reported that the cot got stuck in the ambulance while trying to unload a patient.There were no reported adverse consequences.The customer originally canceled their request for service; however, rescheduled under a different work order.Upon evaluation, it was found that the powerload fastener was unable to release the cot from the ambulance.This is not a reportable issue.

• 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: kelsey barla ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 12720455
• MDR Text Key: 279087000
• Report Number: 0001831750-2021-01617
• 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: 12/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 6390000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/05/2021
• 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