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, 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: 8658165
• MDR Text Key: 146643390
• Report Number: 0001831750-2019-00573
• 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