SMARTMONITOR 2 PS *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-06-25 for SMARTMONITOR 2 PS * manufactured by Respironics, Inc..

Event Text Entries

[16684297] 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). ======================the manufacturer's engineer told the facility there is not a way to adjust the setting.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3933963
• MDR Report Key: 3933963
• Date Received: 2014-06-25
• Date of Report: 2014-05-15
• Date of Event: 2014-03-06
• Report Date: 2014-05-15
• Date Reported to FDA: 2014-06-25
• Date Reported to Mfgr: 2014-07-15
• Date Added to Maude: 2014-07-15
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: SMARTMONITOR 2 PS
• Generic Name: MONITOR, APNEA, FACILITY USE
• Product Code: FLS
• Date Received: 2014-06-25
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: *
• Device Age: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: RESPIRONICS, INC.
• Manufacturer Address: 1010 MURRY RIDGE LANE MURRYSVILLE PA 15668852 US 15668 8525

Device Sequence Number: 2

• Brand Name: SMARTMONITOR 2 PS
• Generic Name: MONITOR, APNEA, FACILITY USE
• Product Code: FLS
• Date Received: 2014-06-25
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: RESPIRONICS, INC.
• Manufacturer Address: 1010 MURRY RIDGE LANE MURRYSVILLE PA 15668852 US 15668 8525

Device Sequence Number: 3

• Brand Name: SMARTMONITOR 2 PS
• Generic Name: MONITOR, APNEA, FACILITY USE
• Product Code: FLS
• Date Received: 2014-06-25
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: RESPIRONICS, INC.
• Manufacturer Address: 1010 MURRY RIDGE LANE MURRYSVILLE PA 15668852 US 15668 8525

Device Sequence Number: 4

• Brand Name: SMARTMONITOR 2 PS
• Generic Name: MONITOR, APNEA, FACILITY USE
• Product Code: FLS
• Date Received: 2014-06-25
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Sequence No: 4
• Device Event Key: 0
• Manufacturer: RESPIRONICS, INC.
• Manufacturer Address: 1010 MURRY RIDGE LANE MURRYSVILLE PA 15668852 US 15668 8525

Device Sequence Number: 5

• Brand Name: SMARTMONITOR 2 PS
• Generic Name: MONITOR, APNEA, FACILITY USE
• Product Code: FLS
• Date Received: 2014-06-25
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Sequence No: 5
• Device Event Key: 0
• Manufacturer: RESPIRONICS, INC.
• Manufacturer Address: 1010 MURRY RIDGE LANE MURRYSVILLE PA 15668852 US 15668 8525

Device Sequence Number: 6

• Brand Name: SMARTMONITOR 2 PS
• Generic Name: MONITOR, APNEA, FACILITY USE
• Product Code: FLS
• Date Received: 2014-06-25
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Sequence No: 6
• Device Event Key: 0
• Manufacturer: RESPIRONICS, INC.
• Manufacturer Address: 1010 MURRY RIDGE LANE MURRYSVILLE PA 15668852 US 15668 8525

Patients

Patient Number	Treatment	Outcome	Date
1	0		2014-06-25