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

Catalog Number 2950200000

Device Problems Hole In Material (1293); Moisture Damage (1405)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/27/2014

Event Type  malfunction  

Event Description

It was reported that the top cover had holes in it with signs of fluid intrusion.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.

Event Description

It was reported that the top cover had holes in it with signs of fluid intrusion.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.

Manufacturer Narrative

Follow-up submitted to revise conclusion code as the top cover was replaced and not repaired.

• 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: pravin betala ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 3638628
• MDR Text Key: 4180555
• Report Number: 0001831750-2014-01536
• 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: 01/27/2014

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: Other
• Device Catalogue Number: 2950200000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/27/2014
• Initial Date FDA Received: 02/21/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/12/2014
• 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