MAUDE Adverse Event Report: STANLEY HEALTHCARE M200

Model Number M200

Device Problems Defective Alarm (1014); Break (1069)

Patient Problem Fall (1848)

Event Date 04/15/2019

Event Type  Injury  

Manufacturer Narrative

On july 1, 2019: (b)(6).Re: medwatch form (b)(4).Dear (b)(6), on 5/20/2019, stanley healthcare (sh) received a medwatch report from your facility reporting device malfunctions.You reported an incident having occurred in (b)(6) 2019.Report indicates the patient fell and the m200 alarm did not sound.Your report also states that your investigation identified the "black cord" used in your application was broken.To date, none of the reported equipment has been returned to sh for further evaluation as requested.My last correspondence with your office was from (b)(6), on, may 30, 2019 1:06 pm cst, wherein mr.(b)(6) stated he was unable to provide additional color regarding the incident.I have additionally reached out to mr.(b)(6) of (b)(6).Per conversation with mr.(b)(6) it was confirmed that a 3rd party "pigtail", used as an extension cord, was the root cause of the failure.Please note, sh did release a technical bulletin dated 12/4/2018 that stated, "stanley healthcare does not recommend the use of third-party accessories such as adaptors, extensions." please find a copy enclosed.In addition, as stated on page iii of the m200 fall monitor setup & user guide, "test the m200 fall monitor and sensormat pad before each use and inspect the cords and pads for signs of damage.Immediately replace any components with signs of wear or damage." if you have any questions, please feel free to contact me at (b)(4).Sincerely, (b)(4).

Event Description

Stanley bed alarm on patient for the purpose of alarming for fall prevention.Patient fell, bed alarm did not ring the alarm.Stanley rep contacted by nurse manager, discovered the black cord used with the alarm was broken.Rep indicated this has happened before with cord.

• Brand Name: M200
• 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
• MDR Report Key: 8840879
• MDR Text Key: 152647561
• Report Number: 1929691-2019-00002
• 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: consumer
• Reporter Occupation: Risk Manager
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 05/20/2019,04/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M200
• Device Catalogue Number: M200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/20/2019
• Date Manufacturer Received: 05/20/2019
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR