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

Catalog Number 5700000000

Device Problem Insufficient Information (3190)

Patient Problem Swelling (2091)

Event Date 12/13/2013

Event Type  Injury  

Event Description

It was reported that a patient's arm allegedly became stuck in the siderail and swelled to the point that it could not be extracted.The siderail was cut in order to remove the patient's arm.

Manufacturer Narrative

Follow-up submitted to report, as the distributor, hill-rom conducted an investigation within hill-rom¿s quality management system under (b)(4).No further investigation is being conducted.Device was evaluated by the distributor.

Event Description

It was reported that a patient's arm allegedly became stuck in the siderail and swelled to the point that it could not be extracted.The siderail was cut in order to remove the patient's arm.

• 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 1R6; CA N6E 1R6
• Manufacturer (Section G): STRYKER MEDICAL LONDON DBA CHG HOSPITAL BEDS; 1020 adelaide st. s.; N6E 1R6; CA N6E 1R6
• Manufacturer Contact: rita moffitt ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 4753136
• MDR Text Key: 19093156
• Report Number: 3006433555-2015-00025
• 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: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 5700000000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/08/2015
• 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