MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO ISOFLEX LAL 84IN W OPTION CVR; MATTRESS, FLOTATION THERAPY, NON-POWERED

Catalog Number 2860000019

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

Patient Problems Tissue Damage (2104); Cardiogenic Shock (2262)

Event Date 05/02/2019

Event Type  Injury  

Event Description

It was reported the patient developed a deep tissue injury.It happened in the cvicu where the patient had a lengthy surgery and cardiogenic shock.No further information has been provided at this time.

Manufacturer Narrative

Updated product information, section h to indicate no evaluation performed.Customer did not allege product caused or contribute to injury.

Event Description

It was reported the patient developed a deep tissue injury.It happened in the cvicu where the patient had a lengthy surgery and cardiogenic shock.No further information has been provided at this time.

• Brand Name: ISOFLEX LAL 84IN W OPTION CVR
• Type of Device: MATTRESS, FLOTATION THERAPY, NON-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: 8658164
• MDR Text Key: 146644127
• Report Number: 0001831750-2019-00576
• Device Sequence Number: 1
• Product Code: IKY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/12/2019

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: 2860000019
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/02/2019
• Initial Date FDA Received: 05/31/2019
• Supplement Dates Manufacturer Received: 05/02/2019
• Supplement Dates FDA Received: 07/12/2019
• 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