MAUDE Adverse Event Report: STRYKER MEDICAL LONDON DBA CHG HOSPITAL BEDS SPIRIT SELECT; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number 5700

Device Problems Break (1069); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/08/2018

Event Type  malfunction  

Event Description

It was reported that the there was reduced brake force due to a damaged brake linkage and a broken caster weld.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.

Event Description

It was reported that the there was reduced brake force due to a damaged brake linkage and a broken caster weld.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.

• Brand Name: SPIRIT SELECT
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): STRYKER MEDICAL LONDON DBA CHG HOSPITAL BEDS; 1020 adelaide st. s.; N6E 1 R6; CA N6E 1R6
• MDR Report Key: 7397192
• MDR Text Key: 104537257
• Report Number: 3006433555-2018-00090
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 07613327284546
• UDI-Public: (01)07613327284546
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 5700
• Device Catalogue Number: 5700000000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1