MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO UNKNOWN_MEDICAL_PRODUCT; STRETCHER, HAND-CARRIED

Catalog Number UNK_MED

Device Problem Difficult or Delayed Positioning (1157)

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

Event Date 09/11/2023

Event Type  malfunction  

Manufacturer Narrative

H3 other text: unable to determine specific device, not available for evaluation.

Event Description

It was reported that the device's rubber tracks are dry rotted.No patient was affected, and no adverse consequence or clinically relevant delay in treatment was reported.

Event Description

It was reported that the device's rubber tracks are dry rotted.No patient was affected, and no adverse consequence or clinically relevant delay in treatment was reported.

Manufacturer Narrative

It was reported by the customer that allegedly the device's rubber tracks are dry rotted, which could cause the stair tread/tracks to be difficult to maneuver the unit (no tip).As a result, a work order was opened for evaluation by a stryker field service representative.However, the customer stated that the issue was resolved under preventive maintenance, and that the customer couldn't identify the serial number for the unit.Therefore, this work order has been canceled.The field service representative confirmed that no further action is required at this time.

• Brand Name: UNKNOWN_MEDICAL_PRODUCT
• Type of Device: STRETCHER, HAND-CARRIED
• 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: alex wibert ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 17899916
• MDR Text Key: 325249369
• Report Number: 0001831750-2023-01021
• Device Sequence Number: 1
• Product Code: FPP
• 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: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: UNK_MED
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/11/2023
• 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