MAUDE Adverse Event Report: STRYKER MEDICAL STRYKER PATIENT MATTRESSES; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Device Problem Moisture Damage (1405)

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

Event Date 10/19/2018

Event Type  malfunction  

Event Description

Neuro science intensive care unit (icu) & trauma icu - 19 patient bed mattresses found to be compromised with fluid ingress.Mattresses removed by environmental services with biomed support.Mattresses will be evaluated and cultured by infection control.Stryker rep coming on site to assess for warranty.Environmental services will be trained to inspect and identify compromised mattresses going forward.24 stryker iso gels were affected.14 out 16 of hillrom accumax were affected.No patient identifiers are available.No known injuries at this time, voluntary.

• Brand Name: STRYKER PATIENT MATTRESSES
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): STRYKER MEDICAL; 3800 e. centre ave.; portage MI 49002
• MDR Report Key: 8054736
• MDR Text Key: 126658391
• Report Number: 8054736
• Device Sequence Number: 1
• Product Code: FNM
• 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: 10/26/2018

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/26/2018
• Event Location: Hospital
• Date Report to Manufacturer: 11/09/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/09/2018
• Type of Device Usage: N
• Patient Sequence Number: 1