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

Catalog Number 2950200000

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Pressure Sores (2326)

Event Date 01/21/2016

Event Type  Injury  

Manufacturer Narrative

It was reported there was no power to the bed, which would result in no power being supplied to the mattress as well.

Event Description

It was reported that a patient developed a pressure ulcer while on a non-functional mattress.

Manufacturer Narrative

This event was reported via user facility medwatch.No serial number, contact information, or account information was provided in the report.The alleged inspection found that the mattress was not receiving power as the bed that it was plugged into had non-functional circuitry.It was reported that the non-stryker bed's outlets could not exceed 3 amps.The items that were plugged into the bed exceeded that limit and damaged the bed circuitry, thus providing no power to the mattress.There was no defect alleged of the mattress, just that it could not inflate because it was not receiving power.The severity of the alleged pressure ulcer could not be determined from the report, and no contact information was provided.

Event Description

It was reported that a patient developed a pressure ulcer while on a non-functional mattress.

• 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: 5721258
• MDR Text Key: 47284391
• Report Number: 0001831750-2016-00193
• 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: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/16/2016

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: 2950200000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/16/2016
• Initial Date FDA Received: 06/13/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/07/2016
• 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