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

Model Number 2972

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

Patient Problem Pressure Sores (2326)

Event Date 02/13/2023

Event Type  Injury  

Event Description

It was reported that the patient sustained a type 2 pressure injury.

Event Description

It was reported that the patient sustained a type 2 pressure injury.

Manufacturer Narrative

The surface was evaluated by a stryker field service technician, who found that the hospital acquired pressure injury was not due to any component level defect or malfunction of the surface.Additionally, a stryker quality assurance engineer spoke with the sales account manager who explained that the mattress had lost power from the bed.The nurse attending to the patient was new and did not check the foot end of the bed to ensure the mattress was powered and detected by the bed.It is unknown how long the surface was without power.The patient received a stage 2 pressure injury.The issue was resolved for the customer by the sales rep conducting additional training with the nurse and confirming no further action is needed by stryker at this time.

• Brand Name: ISOLIBRIUM SUPPORT SURFACE - D
• 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: marleca lane ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 16531252
• MDR Text Key: 311173271
• Report Number: 0001831750-2023-00311
• Device Sequence Number: 1
• Product Code: IKZ
• UDI-Device Identifier: 07613327278453
• UDI-Public: 07613327278453
• 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: 04/06/2023

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?: No
• Device Model Number: 2972
• Device Catalogue Number: 2972000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/13/2023
• Initial Date FDA Received: 03/13/2023
• Supplement Dates Manufacturer Received: 02/13/2023
• Supplement Dates FDA Received: 04/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2021
• 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