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 Problems Tissue Damage (2104); Injury (2348)

Event Date 03/30/2017

Event Type  Injury  

Event Description

It was reported that the cpr release had been pulled causing the mattress to deflate without the caregiver's knowledge for 36+ hours.It was further reported that the patient subsequently developed a deep tissue injury.

Manufacturer Narrative

The issue was resolved for the customer by informing the customer on proper use of the product.

Event Description

It was reported that the cpr release had been pulled causing the mattress to deflate without the caregiver's knowledge for 36+ hours.It was further reported that the patient subsequently developed a deep tissue injury.

Manufacturer Narrative

Supplemental submitted to include udi.

Event Description

It was reported that the cpr release had been pulled causing the mattress to deflate without the caregiver's knowledge for 36+ hours.It was further reported that the patient subsequently developed a deep tissue injury.

• 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: 6529753
• MDR Text Key: 73939175
• Report Number: 0001831750-2017-00148
• 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: 03/26/2018

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: 03/30/2017
• Initial Date FDA Received: 04/28/2017
• Supplement Dates Manufacturer Received: 03/30/2017; 03/30/2017
• Supplement Dates FDA Received: 09/18/2017; 03/26/2018
• 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