MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO GOBED II MED/SURG BED; BED, AC-POWERED ADJUSTABLE HOSPITAL

Catalog Number FL28C

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Date 07/26/2023

Event Type  malfunction  

Event Description

It was reported one of the beds was taken to a patient room, and while connecting the nurse call cable, it allegedly sparked.The plug was plugged into the hospital monitor first, then plug into the bed when it sparked.There was patient involvement, but at this time, no serious injuries or clinically relevant delay in treatment was reported.

Manufacturer Narrative

A stryker senior quality assurance engineer spoke with the sales account manager, who confirmed that there was no adverse event as result of the alleged ¿spark¿ and that the serial number was not identified but the unit may be addressed by procare in the future.Based on the event description and discussion, it was determined that the alleged ¿spark¿ was likely not due to any component level defect as there were no alleged defects present.The issue was resolved for the customer by documenting the complaint and informing them that stryker procare may evaluate the unit if it is made available in the future.

Event Description

It was reported one of the beds was taken to a patient room, and while connecting the nurse call cable, it allegedly sparked.The plug was plugged into the hospital monitor first, then plug into the bed when it sparked.There was patient involvement, but no serious injuries or clinically relevant delay in treatment was reported.

• Brand Name: GOBED II MED/SURG BED
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• 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: marleca lane ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 17413667
• MDR Text Key: 320041460
• Report Number: 0001831750-2023-00967
• Device Sequence Number: 1
• Product Code: FNL
• 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: 11/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: FL28C
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/26/2023
• 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