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

Catalog Number 2950000000

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/02/2016

Event Type  malfunction  

Event Description

It was reported that the mattress had a burned plug receptacle.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.

Manufacturer Narrative

Supplemental submitted to indicate that the unit was repaired and returned.The investigation concluded that a likely cause for the burn marks could have been due to an overload situation or high current spikes.

Event Description

It was reported that the mattress had a burned plug receptacle.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.

• 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: mary klaver ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 5691136
• MDR Text Key: 46288793
• Report Number: 0001831750-2016-00186
• 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: 05/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 05/02/2016
• Initial Date FDA Received: 06/01/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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