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

Model Number FL28C

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Bruise/Contusion (1754); Laceration(s) (1946); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/01/2021

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 is pending evaluation.There was no remedial action taken.This device is not labeled for single use.

Event Description

This report summarizes 1 malfunction event, where it was reported the device experienced pinch/crush points.There was patient involvement; no adverse consequences were reported.

Manufacturer Narrative

Upon investigation of the alleged event, there was no product malfunction; the issue was the result of use error.The h codes have been updated to include patient involvement information.

Event Description

This report summarizes 1 malfunction event, where it was reported the device experienced pinch/crush points.There was patient involvement; the patient experienced temporary impairment.

• 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
• MDR Report Key: 12238861
• MDR Text Key: 263851451
• Report Number: 0001831750-2021-01282
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 07613327169355
• UDI-Public: 07613327169355
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 09/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: FL28C
• Device Catalogue Number: FL28C
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1