MAUDE Adverse Event Report: STRYKER BED, SPIRIT SELECT

Model Number N3A02BCEFM

Device Problems Sticking (1597); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

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

Event Date 09/28/2015

Event Type  malfunction  

Event Description

Stryker/chg spirit select low bed would not go down from the highest position and alarmed "obstruction check under bed".There was no obstruction under the bed.We have 9 of these beds that were received last month, (b)(6) 2015 and this is the second bed with this failure.The failure of the obstruction sensor can place the patient at great risk of a fall from the beds full height with no way for the user or patient to lower the bed without disabling the sensor.

• Brand Name: BED, SPIRIT SELECT
• Type of Device: BED, SPIRIT SELECT
• Manufacturer (Section D): STRYKER
• MDR Report Key: 5127247
• MDR Text Key: 27529202
• Report Number: MW5056802
• Device Sequence Number: 1
• Product Code: FNL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Report Date: 09/29/2015

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: Health Professional
• Device Model Number: N3A02BCEFM
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/29/2015
• Type of Device Usage: N
• Patient Sequence Number: 1