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

Catalog Number 5700000000

Device Problems Component Falling (1105); Device Slipped (1584)

Patient Problems Bone Fracture(s) (1870); Laceration(s) (1946)

Event Date 09/20/2017

Event Type  Injury  

Event Description

It was reported that a technician was attempting to replace a hi-lo actuator.The technician allegedly pulled the pin out of the actuator mount point and the bed dropped slightly.When the bed dropped, the technician reportedly caught his thumb between the actuator and the frame of the bed, causing a fracture and laceration.It was further alleged that the technician required a skin graft and surgery following the event.

Manufacturer Narrative

The issue was resolved for the customer by sending service instructions to the customer, who confirmed that the bed was successfully repaired.

Event Description

It was reported that a technician was attempting to replace a hi-lo actuator.The technician allegedly pulled the pin out of the actuator mount point and the bed dropped slightly.When the bed dropped, the technician reportedly caught his thumb between the actuator and the frame of the bed, causing a fracture and laceration.It was further alleged that the technician required a skin graft and surgery following the event.

• 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.; N6E 1 R6; CA N6E 1R6
• Manufacturer Contact: mary klaver ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 6959768
• MDR Text Key: 89676093
• Report Number: 3006433555-2017-00169
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 5700000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/20/2017
• Initial Date FDA Received: 10/18/2017
• Supplement Dates Manufacturer Received: 09/20/2017
• Supplement Dates FDA Received: 12/04/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/21/2012
• 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
• Patient Outcome(s): Required Intervention