MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO ISOFLEX 35X84 DARTEX W/FB; BED, FLOTATION THERAPY, POWERED

Catalog Number 2800000000

Device Problem Increase in Pressure (1491)

Patient Problem No Code Available (3191)

Event Date 09/14/2018

Event Type  Injury  

Event Description

The customer reported a general increase in pressure injuries.No specific incidents were reported.

Manufacturer Narrative

Investigation determined the complaint was entered with an incorrect product.The product is not manufactured by stryker.Hill-rom, the manufacturer is responsible for all regulatory reporting and complaint handling and closure.This complaint was sent to hill-rom for regulatory reporting determination.

Event Description

The customer reported a general increase in pressure injuries.No specific incidents were reported.

• Brand Name: ISOFLEX 35X84 DARTEX W/FB
• Type of Device: BED, FLOTATION THERAPY, 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: 7955427
• MDR Text Key: 123359765
• Report Number: 0001831750-2018-01088
• Device Sequence Number: 1
• Product Code: IOQ
• 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: 01/14/2019

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: No Information
• Device Catalogue Number: 2800000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/14/2018
• Initial Date FDA Received: 10/11/2018
• Supplement Dates Manufacturer Received: 09/14/2018
• Supplement Dates FDA Received: 01/14/2019
• 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