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

Catalog Number 2971000000

Device Problem Insufficient Information (3190)

Patient Problem Pressure Sores (2326)

Event Date 11/18/2016

Event Type  Injury  

Event Description

It was reported that the patient developed a pressure ulcer.No details regarding the extent of the injury or any medical intervention was given.

Manufacturer Narrative

The issue was resolved for the customer by training the staff on how to use the cpr release and where to find the error messages.

Event Description

It was reported that the cpr was released on the mattresses causing the mattress to deflate with a patient on the unit, without the staff at the account realizing that the cpr had been pulled.No defect was found with the unit.It was further reported that the patient developed a pressure ulcer, which was not greater than stage 3.No details of medical intervention were reported.

Manufacturer Narrative

Supplemental submitted to include udi.

Event Description

It was reported that the cpr was released on the mattresses causing the mattress to deflate with a patient on the unit, without the staff at the account realizing that the cpr had been pulled.No defect was found with the unit.It was further reported that the patient developed a pressure ulcer, which was not greater than stage 3.No details of medical intervention were 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: kristen canter ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 6175179
• MDR Text Key: 62459919
• Report Number: 0001831750-2016-00398
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 03/27/2018

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?: No
• Initial Date Manufacturer Received: 11/18/2016
• Initial Date FDA Received: 12/15/2016
• Supplement Dates Manufacturer Received: Not provided; 11/18/2016
• Supplement Dates FDA Received: 01/31/2017; 03/27/2018
• 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