MAUDE Adverse Event Report: STRYKER CORPORATION SPIRIT SELECT; BED, AC-POWERED ADJUSTABLE

Device Problems Mechanical Problem (1384); Sticking (1597); Positioning Problem (3009)

Patient Problem No Information (3190)

Event Date 09/14/2017

Event Type  malfunction  

Event Description

Moving a patient via elevator to pediatrics post op via elevator.When the nurse and transporter attempted to move the bed off of the elevator the wheel of the patient bed became stuck in the gap between the elevator car and landing.Facilities was called to assist and removed the stuck wheel using a j bar.A review of the event noted that all patient beds have wheels of the same diameter and that the wheels may become stuck in the gap between elevator car and landing when they are swiveling.The gap in the elevator is a standard gap with a minor plus or minus deviation and cannot be reduced due to seismic sensors on the elevator.Those transporting patients have been reminded to check for proper wheel alignment and signage has been placed on elevators used for patient transport.Concern was should a patient be transported emergently, or code, that there is a serious potential for negative impact to the patient should the bed become stuck.

• Brand Name: SPIRIT SELECT
• Type of Device: BED, AC-POWERED ADJUSTABLE
• Manufacturer (Section D): STRYKER CORPORATION; 3800 e. centre avenue; portage MI 49002
• MDR Report Key: 6934443
• MDR Text Key: 88849703
• Report Number: 6934443
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/28/2017
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 19 YR
• Patient Weight: 61