MAUDE Adverse Event Report: STANLEY HEALTHCARE STANLEY HEALTHCARE; M200

Model Number M200

Device Problem Defective Alarm (1014)

Patient Problem Fall (1848)

Event Date 12/15/2020

Event Type  Injury  

Manufacturer Narrative

(b)(6) 2021.(b)(6).Medwatch form (b)(4).(b)(6).On 1/19/2021, stanley healthcare (sh) received a medwatch report from your facility reporting device malfunctions.You reported an incident having occurred in (b)(6) 2020; the patient was found on the floor with injuries, and the bed alarm had not sounded.Stanley subsequently reached out to (b)(4) for context.(b)(4) serves as a partner to stanley it was our intention to request the product in question be returned to stanley for further evaluation.Furthermore (b)(4) reached out to (b)(6) (clinical engineering manager, (b)(6) hospital) as well as yourself.Consequently, you confirmed in your email dated 1/26/2021 that the device in question could not be located.Due to not being able to evaluate the device in question, i am closing out this filing citing no further action required by stanley healthcare.Please note stanley actively monitors customer complaints, and there are no active investigations that would indicate (b)(4) device malfunctioned.Please also note that per the fda's "medical device reporting for user facilities" states, "[?] fda has no legal authority to require that a device be returned to the manufacturer or that a manufacturer have access to the device.However, fda believes that the manufacturer of a device should evaluate any problems with its device.Fda encourages users to permit access to or return of the device to the manufacturer for evaluation." in lieu of evaluation of your device i would like to emphasize the importance of the testing operation defined on page 20 of the m200 user manual.This section outlines the proper testing protocol to be used when arming the m200 fall monitor.A copy of this user manual is included with this letter for reference.If you have any questions, please feel free to contact, (b)(4).

Event Description

Per (b)(4)."patient had bed alarm in place.Patient was found on the floor with injuries, and bed alarm did not go off.An open wire was found on the device after the incident".

• Brand Name: STANLEY HEALTHCARE
• Type of Device: M200
• Manufacturer (Section D): STANLEY HEALTHCARE; 4600 vine street; lincoln NE 68503
• Manufacturer (Section G): STANLEY HEALTHCARE; 4600 vine street; lincoln NE 68503
• Manufacturer Contact: garth jack ; 4600 vine street; lincoln, NE 68503 ; 4027429335
• MDR Report Key: 11282971
• MDR Text Key: 230438376
• Report Number: 1929691-2021-00002
• Device Sequence Number: 1
• Product Code: KMI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Nurse Practitioner
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 02/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M200
• Device Catalogue Number: M200
• Device Lot Number: H6051S00290T
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 74 YR