MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO XPRT MATTRESS W/O PENDANT; BED, PATIENT ROTATION, POWERED

Catalog Number 2950200000

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Pressure Sores (2326)

Event Date 07/21/2016

Event Type  Injury  

Manufacturer Narrative

The customer confirmed that the mattress was displaying an error code for a bladder leak at the time that it was found, indicating a surface issue.The staff members were unsure, however, how long the mattress had been indicating the error.

Event Description

It was reported by the customer, while inquiring about the potential addition of an alarm to the mattress when there is an issue with the surface, that a patient had developed a stage 4 pressure injury.The customer additionally reported there were multiple factors in the progression of the patient's wound.

Manufacturer Narrative

An evaluation was performed by the user facility.The account confirmed that they do not know how long the patient was on the mattress while it was displaying an error message and not fully inflated.The account also stated that there are multiple progressions to the severity of this injury, and did not believe the mattress to be the sole contributor.

Event Description

It was reported by the customer, while inquiring about the potential addition of an alarm to the mattress when there is an issue with the surface, that a patient had developed a stage 4 pressure injury.The customer additionally reported there were multiple factors in the progression of the patient's wound.

• Brand Name: XPRT MATTRESS W/O PENDANT
• 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: mary klaver ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 5889733
• MDR Text Key: 52545474
• Report Number: 0001831750-2016-00264
• 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: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 2950200000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/21/2016
• 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