MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS, INC. STANLEY BED CHECK ALARM PAD; MONITOR, BED PATIENT

Model Number 74030

Device Problem Defective Alarm (1014)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/21/2020

Event Type  malfunction  

Event Description

The patient was found standing in the room a few feet from her bed with her wound vac half removed.The bed alarm did not sound.Everything was plugged in correctly, but the bed alarm indicator on the wall was a solid green.Nurse applied pressure to the bed alarm and removed the pressure, but this did not set it off.Nurse physically manipulated the alarm pad, folding part of it, and this did cause it to go off.

• Brand Name: STANLEY BED CHECK ALARM PAD
• Type of Device: MONITOR, BED PATIENT
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS, INC.; 1810 west drake drive; tempe AZ 85283
• MDR Report Key: 10655346
• MDR Text Key: 210616119
• Report Number: 10655346
• Device Sequence Number: 1
• Product Code: KMI
• 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: 09/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2020
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 74030
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/25/2020
• Event Location: Hospital
• Date Report to Manufacturer: 10/09/2020
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 21170 DA
• Patient Weight: 39