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

Catalog Number 5700000000

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 03/31/2015

Event Type  malfunction  

Event Description

It was reported that there was a "downward interrupt motion error" on the bed.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.

Manufacturer Narrative

Supplemental report submitted with results of investigation, which determined the bed lift was stuck in high height, and could not be lowered.This is an annoyance issue only and is not likely to cause or contribute to serious injury or death if it was to recur.

Event Description

It was reported that there was a "downward interrupt motion error" on the bed.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 (MDR); 1020 adelaide st. s.; N6E1R ; CA N6E1R
• Manufacturer (Section G): STRYKER MEDICAL LONDON DBA CHG HOSPITAL BEDS (MDR); 1020 adelaide st. s.; N6E1R ; CA N6E1R
• Manufacturer Contact: mary klaver ; 1020 adelaide st. s.; portage, MI N6E1R ; CA N6E1R ; 5199634010
• MDR Report Key: 4741397
• MDR Text Key: 19313031
• Report Number: 3006433555-2015-00006
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 5700000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/31/2015
• 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