MAUDE Adverse Event Report: STRYKER BED

Device Problems Device Maintenance Issue (1379); Unintended Collision (1429)

Patient Problem Injury (2348)

Event Date 02/23/2014

Event Type  Injury  

Event Description

Frequent problem with stryker motorized beds that are malfunctioning.Addressed with manager who is stating that it is the operator and not the bed even though those problems have occurred frequently one time almost extubated pt, reported a personal injury to a nurse from the bed running full speed into her.Beds are not being maintained and serviced properly.Stryker beds frequently malfunctioning and potentially can cause harm to pts.Staff have experienced injury.Because of malfunctioning beds.

• Brand Name: BED
• Type of Device: BED
• Manufacturer (Section D): STRYKER
• MDR Report Key: 3885807
• MDR Text Key: 20856109
• Report Number: MW5036693
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 06/13/2014

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/16/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 64 YR
• Patient Weight: 91