MAUDE Adverse Event Report: STRYKER MEDICAL POSITION PRO; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number 2920

Device Problem Device Alarm System (1012)

Patient Problem No Information (3190)

Event Date 10/01/2014

Event Type  malfunction  

Event Description

The bed alarms sound exactly like a patient exit alarm.When assessing the patient they are in their bed not moving.Upon examination of the foot board screen the only sign that appears is to "notify maintenance".The only way staff know how to stop that alarm is to unplug the bed and plug it back in again.

• Brand Name: POSITION PRO
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): STRYKER MEDICAL; 3800 east centre avenue; portage MI 49002
• MDR Report Key: 4585012
• MDR Text Key: 5479488
• Report Number: 4585012
• Device Sequence Number: 1
• Product Code: FNM
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 01/27/2015

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: Invalid Data
• Device Model Number: 2920
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/27/2015
• Event Location: Hospital
• Date Report to Manufacturer: 03/10/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/27/2015
• Patient Sequence Number: 1