MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO ISOAIR PUMP; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number 2941

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problem Pressure Sores (2326)

Event Date 03/15/2022

Event Type  Injury  

Event Description

It was reported that a patient sustained a stage 4 pressure injury on an isoair support surface.Attempts are being made to gather more details from the user facility.

Manufacturer Narrative

This supplemental is being filed to correct the model number and serial number of the device.

Event Description

It was reported that a patient sustained a stage 4 pressure injury on an isoair support surface.Attempts are being made to gather more details from the user facility.

Manufacturer Narrative

A stryker staff design engineer evaluate the unit, where he found that the deflated central air bladders were due to kinking of the side bolster pressure sensor tube.The pump was returned to stryker and further evaluated, where it was determined that the pump properly prompted the disconnect air hose alarm.The patient sustained a stage 4 pressure injury on the surface, however, the patient was designated as high risk for a pressure injury.

Event Description

It was reported that a patient sustained a stage 4 pressure injury on an isoair support surface.

• Brand Name: ISOAIR PUMP
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• 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: marleca lane ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 13826147
• MDR Text Key: 287679581
• Report Number: 0001831750-2022-00267
• Device Sequence Number: 1
• Product Code: FNM
• UDI-Device Identifier: 07613327503999
• UDI-Public: 07613327503999
• 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: 05/11/2023

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?: Yes
• Device Model Number: 2941
• Device Catalogue Number: 2941001001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/15/2022
• Initial Date FDA Received: 03/19/2022
• Supplement Dates Manufacturer Received: 03/15/2022; 03/15/2022
• Supplement Dates FDA Received: 03/24/2022; 05/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/27/2020
• 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
• Patient Outcome(s): Other