MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO XPRT SLEEP SURFACE; BED, PATIENT ROTATION, POWERED

Catalog Number 2950000000

Device Problem Defective Device (2588)

Patient Problem Pressure Sores (2326)

Event Date 01/27/2016

Event Type  Injury  

Event Description

It was reported that a patient allegedly sustained a pressure ulcer due to the mattress deflating from a defective power board.

Manufacturer Narrative

Follow-up submitted with evaluation results provided by customer which confirmed a power board malfunction caused the xprt mattress to deflate.Product information has been added, however, the serial number of the unit was not recorded and the severity of the pressure ulcer was not disclosed.Customer performed repairs.Customer performed evaluation.

Event Description

It was reported that a patient allegedly sustained a pressure ulcer due to the mattress deflating from a defective power board.

• Brand Name: XPRT SLEEP SURFACE
• 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: rita moffitt ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 5457970
• MDR Text Key: 38960798
• Report Number: 0001831750-2016-00067
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/29/2016

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?: Yes
• Device Operator: No Information
• Device Catalogue Number: 2950000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/29/2016
• Initial Date FDA Received: 02/24/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/09/2016
• 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