MAUDE Adverse Event Report: STRYKER CORPORATION ISOGEL; BED, FLOTATION THERAPY, POWERED

Model Number ISOGEL

Device Problem Defective Device (2588)

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

Event Date 10/19/2018

Event Type  malfunction  

Event Description

Stryker isogel mattress was compromised and not appropriate for patients, switched out for clean bed.

• Brand Name: ISOGEL
• Type of Device: BED, FLOTATION THERAPY, POWERED
• Manufacturer (Section D): STRYKER CORPORATION; 3800 e. centre ave.; portage MI 49002
• MDR Report Key: 8063656
• MDR Text Key: 126943595
• Report Number: 8063656
• Device Sequence Number: 1
• Product Code: IOQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/31/2018

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 Model Number: ISOGEL
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/31/2018
• Event Location: Hospital
• Date Report to Manufacturer: 11/13/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/13/2018
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 27375 DA