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

Catalog Number 5800000000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Date 12/22/2017

Event Type  Injury  

Manufacturer Narrative

It was reported that this event resulted in a worker's compensation claim, but no details regarding the claim were given.

Event Description

It was reported that the user was attempting to re-position the bed and in the process received an unspecified elbow injury.It was further reported that this caused the user to be unable to lift weight, but no details of any possible medical intervention were given.No defects were alleged with the bed, and no patient involvement was reported.

Manufacturer Narrative

No defects were alleged with the unit, and the issue was resolved for the customer by confirming no further assistance was required.

Event Description

It was reported that the user was attempting to re-position the bed and in the process received an unspecified elbow injury.It was further reported that this caused the user to be unable to lift weight, but no details of any possible medical intervention were given.No defects were alleged with the bed, and no patient involvement was reported.

• Brand Name: SPIRIT PLATFORM
• Type of Device: BED, MANUAL
• 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: chanda burghard ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 7203674
• MDR Text Key: 97675423
• Report Number: 3006433555-2018-00016
• 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,Followup
• Report Date: 03/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 5800000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/22/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/16/2015
• 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