MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO ISOLIBRIUM SUPPORT SURFACE - N; BED, PATIENT ROTATION, POWERED

Catalog Number 2971000000

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

Patient Problem Injury (2348)

Event Date 06/23/2016

Event Type  Injury  

Manufacturer Narrative

No defect reported that would be cause for an evaluation.

Event Description

It was alleged that an employee lifted up a mattress with one hand and was cleaning underneath it with the other hand, but then dropped the mattress on her hand.This allegedly caused an injury that kept her out of work for several weeks.No patient involvement was reported.

Manufacturer Narrative

The issue was resolved for the customer by the sales rep discussing proper cleaning practices with the account (which requires two staff members to maneuver the mattress per the user manual) and confirming that nothing further was required at this time.

Event Description

It was alleged that an employee lifted up a mattress with one hand and was cleaning underneath it with the other hand, but then dropped the mattress on her hand.This allegedly caused an injury that kept her out of work for several weeks.No medical intervention and no patient involvement was reported.

• Brand Name: ISOLIBRIUM SUPPORT SURFACE - N
• Type of Device: BED, PATIENT ROTATION, POWERED
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer (Section G): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer Contact: chanda burghard ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 5866842
• MDR Text Key: 51814345
• Report Number: 0001831750-2016-00253
• Device Sequence Number: 1
• Product Code: IKZ
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/13/2016

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?: No
• Device Operator: No Information
• Device Catalogue Number: 2971000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/13/2016
• Initial Date FDA Received: 08/10/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/21/2016
• 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