MAUDE Adverse Event Report: STRYKER MEDICAL LONDON DBA CHG HOSPITAL BEDS SPIRIT PLATFORM; BED, MANUAL

Catalog Number 5800000000

Device Problem Use of Device Problem (1670)

Patient Problems Fall (1848); Head Injury (1879)

Event Date 02/08/2012

Event Type  Injury  

Event Description

It was reported that the patient slid off the edge of the bed on the mattress and was found on the floor with an alleged head injury which required sutures.

Manufacturer Narrative

The customer did not allege a malfunction with the unit and was, therefore, not evaluated.Chg hospital beds, inc.Was acquired by stryker on jan.2, 2015.  this medwatch is being submitted late because it was identified during the  integration and remediation activities initiated by stryker medical in conjunction with this acquisition.   no malfunction was alleged by the customer.

• Brand Name: SPIRIT PLATFORM
• Type of Device: BED, MANUAL
• 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: mary klaver ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 4879376
• MDR Text Key: 6263139
• Report Number: 3006433555-2015-00309
• Device Sequence Number: 1
• Product Code: FNJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/08/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 5800000000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/08/2012
• 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