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

Catalog Number 2950000000

Device Problems Inflation Problem (1310); Inadequate or Insufficient Training (1643)

Patient Problem Skin Erosion (2075)

Event Date 11/07/2013

Event Type  Injury  

Event Description

It was reported, the patient's skin broke down on the mattress.It was further reported by the user facility that the patient was a larger male and his condition was "complicated." the mattress was rented by the facility for pulmonary and positioning purposes, and due to lack of training or understanding of the product, the patient was left on an underinflated mattress for 4 days.The unit was evaluated by the rental company (a non-stryker entity) and no malfunction was found.

Manufacturer Narrative

The manufacturer did not evaluate the unit; however, the rental company (a non-stryker entity) who provided the unit to the user facility did evaluate the unit and no reported malfunction or defect was detected.The facility rented 2 xprt mattresses, and the mattress on which the alleged event took place could not be confirmed.Since the event, the user facility has received product training on the mattress by stryker personnel.No serial number recorded; however, rental company did perform evaluation.

• 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: pravin betala ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 3840982
• MDR Text Key: 4661693
• Report Number: 0001831750-2014-03028
• 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: Nurse
• Type of Report: Initial
• Report Date: 11/07/2013

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: Other
• Device Catalogue Number: 2950000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/07/2013
• Initial Date FDA Received: 05/30/2014
• 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