MAUDE Adverse Event Report: RESPIRONICS, INC. SMARTMONITOR 2 PS; MONITOR, APNEA, FACILITY USE

Device Problem No Audible Alarm (1019)

Patient Problem No Information (3190)

Event Date 03/06/2014

Event Type  malfunction  

Event Description

A 6-8 new monitors were purchased for the nicu and the expectation was that the alarms would be similar to the older version of the device.We have received complaints from the nursing staff that these newer models do not alarm loud enough.A case number was given to our facility when we called in the complaint to the manufacturer.The manufacturer's engineer reported to our biomed that there was not a way to adjust the volume alarm setting.Another call was made to the manufacturer and we were given a second case number.Manufacturer response for apnea/cardiac monitor, smartmonitor 2 ps (per site reporter).
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the manufacturer's engineer told the facility there is not a way to adjust the setting.

• Brand Name: SMARTMONITOR 2 PS
• Type of Device: MONITOR, APNEA, FACILITY USE
• Manufacturer (Section D): RESPIRONICS, INC.; 1010 murry ridge lane; murrysville PA 15668 852
• MDR Report Key: 3933963
• MDR Text Key: 16684297
• Report Number: 3933963
• Device Sequence Number: 1
• Product Code: FLS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Invalid Data
• Type of Report: Initial
• Report Date: 05/15/2014
• 6 Devices were Involved in the Event: 1 2 3 4 5 6

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/25/2014
• Event Location: Hospital
• Date Report to Manufacturer: 07/15/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NO OTHER THERAPIES