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

Model Number FL28EX

Device Problem Incorrect Measurement (1383)

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

Event Date 10/01/2022

Event Type  malfunction  

Manufacturer Narrative

This record is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.17 devices were functionally/visually inspected in the field.The devices were repaired and returned to use.There was no remedial action taken.This device is not labeled for single use.

Event Description

This report summarizes 17 malfunction events, where it was reported the devices experienced incorrect measurement.There was no patient involvement.

Manufacturer Narrative

This supplemental is being filed to include an additional results code following the completion of a device investigation.

Event Description

This report summarizes 17 malfunction events, where it was reported the devices experienced incorrect measurement.There was no patient involvement.

• Brand Name: GOBED II
• 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: brandon luckas ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 15683381
• MDR Text Key: 305184704
• Report Number: 0001831750-2022-01180
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 17
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: FL28EX
• Device Catalogue Number: FL28EX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/01/2022
• Initial Date FDA Received: 10/27/2022
• Supplement Dates Manufacturer Received: 10/01/2022
• Supplement Dates FDA Received: 12/19/2022
• 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