MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO UNKNOWN_MEDICAL_PRODUCT; BED, PATIENT ROTATION, POWERED

Catalog Number UNK_MED

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

Patient Problem Pressure Sores (2326)

Event Date 12/28/2022

Event Type  Injury  

Event Description

It was reported that a patient sustained a hospital-acquired pressure injury (hapi).Attempts are being made to gather additional details from the user facility.

Event Description

It was reported that a patient sustained a hospital-acquired pressure injury (hapi), which evolved to an unstageable wound and was treated with an enzymatic debriding agent (santyl).When the patient was removed from the bed, it was noted that the surface was deflated.However, none of the staff members documented the serial number of the device involved in the alleged event.

Manufacturer Narrative

Additional information has been obtained.Reportability and section h codes have been updated to reflect these changes.A technician evaluated several similar devices after the event, but none of these displayed a defect or malfunction.There are many factors that contribute to pressure injury development including heat, moisture, pressure braden scale ratings, patient mobility, nursing monitoring, and rotation schedules.Therefore, we cannot conclusively determine whether the product malfunctioned or if there was a use error that caused or contributed to the alleged injury.H3 other text : unable to determine specific device, not available for evaluation.

• Brand Name: UNKNOWN_MEDICAL_PRODUCT
• 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: alex wibert ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 16250393
• MDR Text Key: 308212642
• Report Number: 0001831750-2023-00245
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: UNK_MED
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/28/2022
• 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
• Patient Outcome(s): Other