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

Model Number FL28EX

Device Problem No Audible Alarm (1019)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 07/26/2021

Event Type  Injury  

Event Description

It was reported that the bed alarm did not activate when a patient fall occurred.It was further reported that as a result of the fall, the patient experienced a fracture.Attempts are being made to gather additional injury/treatment details from the user facility.

Event Description

It was reported that the bed alarm did not activate when a patient fall occurred.It was further reported that as a result of the fall, the patient experienced a femur fracture.Upon further communication with the user facility, it was found that the alarm was not set correctly due to user error.

Manufacturer Narrative

Upon further communication with the user facility, it was found that the alarm was not set correctly due to user error.

• 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: melanie shepard ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 12526522
• MDR Text Key: 273131979
• Report Number: 0001831750-2021-01331
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 07613327169386
• UDI-Public: 07613327169386
• 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: 11/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 09/15/2021
• Initial Date FDA Received: 09/24/2021
• Supplement Dates Manufacturer Received: 09/15/2021
• Supplement Dates FDA Received: 11/08/2021
• 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
• Patient Outcome(s): Other