MAUDE Adverse Event Report: STANLEY HEALTHCARE STANLEY HEALTHCARE; CHAIR SENSORMAT PAD

Model Number 73030

Device Problems Device Alarm System (1012); Failure to Sense (1559); Device Sensing Problem (2917)

Patient Problems Facial Nerve Paralysis (1846); Hemorrhage, Subarachnoid (1893)

Event Date 03/29/2018

Event Type  Injury  

Event Description

Pt was found on floor by staff.Pt had been placed in geriatric chair with chair alarm pad underneath pt.Chair alarm did not alarm when pt exited chair unassisted.Staff responded.Upon inspection of chair alarm, chair pad was not functioning properly.Pt transferred to higher level of care.Results revealed acute bilateral subarachnoid hemorrhage.

• Brand Name: STANLEY HEALTHCARE
• Type of Device: CHAIR SENSORMAT PAD
• Manufacturer (Section D): STANLEY HEALTHCARE ; waltham MA
• MDR Report Key: 8691211
• MDR Text Key: 147874117
• Report Number: 8691211
• Device Sequence Number: 1
• Product Code: KMI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 73030
• Device Lot Number: AG0617
• 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: 04/04/2018
• Distributor Facility Aware Date: 03/29/2018
• Event Location: Hospital
• Date Report to Manufacturer: 04/04/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other
• Patient Age: 55 YR
• Patient Weight: 63