MAUDE Adverse Event Report: STRYKER MEDICAL LONDON DBA CHG HOSPITAL BEDS ISOFLEX LAL 2860; BED, FLOTATION THERAPY, POWERED

Catalog Number 2860000000

Device Problem Insufficient Information (3190)

Patient Problems Pressure Sores (2326); Injury (2348)

Event Date 06/18/2018

Event Type  Injury  

Event Description

It was alleged that the customer was experiencing a general increase in pressure injuries to patients while using stryker surfaces.No specific incident(s) were reported, and no details were provided regarding any possible medical intervention.Further, no defects were alleged with the units involved in the alleged events.

Manufacturer Narrative

The customer did not make the units available for inspection and therefore the cause of the alleged injuries cannot be confirmed.

Event Description

It was alleged that the customer was experiencing a general increase in pressure injuries to patients while using stryker surfaces.No specific incident(s) were reported, and no details were provided regarding any possible medical intervention.Further, no defects were alleged with the units involved in the alleged events.

• Brand Name: ISOFLEX LAL 2860
• Type of Device: BED, FLOTATION THERAPY, POWERED
• Manufacturer (Section D): STRYKER MEDICAL LONDON DBA CHG HOSPITAL BEDS; 1020 adelaide st. s.; portage MI N6E 1 R6; CA N6E 1R6
• Manufacturer (Section G): STRYKER MEDICAL LONDON DBA CHG HOSPITAL BEDS; 1020 adelaide st. s.; portage MI N6E 1 R6; CA N6E 1R6
• Manufacturer Contact: chanda burghard ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 7691803
• MDR Text Key: 114138830
• Report Number: 0001831750-2018-00669
• 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: 08/07/2018

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: 2860000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/18/2018
• Initial Date FDA Received: 07/16/2018
• Supplement Dates Manufacturer Received: 06/18/2018
• Supplement Dates FDA Received: 08/07/2018
• Was Device Evaluated by Manufacturer?: No
• 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