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

Catalog Number 5700000000

Device Problem Scratched Material (3020)

Patient Problem Laceration(s) (1946)

Event Date 10/14/2016

Event Type  malfunction  

Event Description

It was reported that there was a sharp metal edge on the retaining rings of the bed's footboard, and a nurse cut herself on one.The cut was not severe enough to require stitches, and she did not require any additional medical intervention.No further information regarding the event was reported at this time.

Manufacturer Narrative

There was no defect alleged with this product, and the issue was resolved for the customer by confirming that nothing further was needed at this time.

Event Description

It was reported that there was a sharp metal edge on the retaining rings of the bed's footboard, and a nurse cut herself on one.The cut was not severe enough to require stitches, and she did not require any additional medical intervention.

Manufacturer Narrative

Corrected "manufacturing site for devices".

Event Description

It was reported that there was a sharp metal edge on the retaining rings of the bed's footboard, and a nurse cut herself on one.The cut was not severe enough to require stitches, and she did not require any additional medical intervention.

Event Description

It was reported that there was a sharp metal edge on the retaining rings of the bed's footboard, and a nurse cut herself on one.The cut was not severe enough to require stitches, and she did not require any additional medical intervention.

• 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
• Manufacturer (Section G): STRYKER MEDICAL LONDON DBA CHG HOSPITAL BEDS; 1020 adelaide st. s.; portage MI N6E 1 R6; CA N6E 1R6
• Manufacturer Contact: kristen canter ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 6096300
• MDR Text Key: 60085127
• Report Number: 3006433555-2016-00250
• 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: other
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 5700000000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/14/2016
• Initial Date FDA Received: 11/11/2016
• Supplement Dates Manufacturer Received: Not provided; 10/14/2016; 10/14/2016
• Supplement Dates FDA Received: 01/03/2017; 09/29/2017; 04/05/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/15/2012
• 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