MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO ISOFLEX MEDSURG MATTRESS MODEL; MATTRESS, FLOTATION THERAPY, NON-POWERED

Catalog Number 2800100997

Device Problems Break (1069); Moisture Damage (1405)

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

Event Date 03/07/2014

Event Type  malfunction  

Event Description

It was reported via repair work order that the top cover was damaged and there was fluid intrusion.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.

Manufacturer Narrative

Conclusion: replaced top and bottom mattress covers and fire barrier sock.

• Brand Name: ISOFLEX MEDSURG MATTRESS MODEL
• Type of Device: MATTRESS, FLOTATION THERAPY, NON-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: 3690651
• MDR Text Key: 21237488
• Report Number: 0001831750-2014-02476
• Device Sequence Number: 1
• Product Code: IKY
• 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
• Report Date: 03/07/2014

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: 2800100997
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/07/2014
• Initial Date FDA Received: 03/20/2014
• 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