MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC. RESUSCITIARE RADIANT WARMER; INFANT RADIANT WARMER

Device Problems Device Alarm System (1012); Output Problem (3005)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/27/2019

Event Type  Injury  

Manufacturer Narrative

A follow-up report will be submitted upon completion of this investigation.

Event Description

It was reported that 2-3 hours with baby saturation wasn't good, no alarm, no more oxygen.

Manufacturer Narrative

It was clarified that no adverse patient impact was reported.The reported failure to alarm for no oxygen on the resuscitaire could not be verified during the evaluation performed by the draeger technician by phone with the hospital respiratory therapist on site, the device alarmed accordingly.No malfunctions were identified and no parts were replaced.No further issues have been reported.This is an isolated case.The resuscitiare instructions for use provides the following: warning monitor the concentration of oxygen provided and the partial pressure of oxygen in the patient blood (pao2).Failure to do so could result in patient injury.Warning do not leave the patient unattended when using the autobreath resuscitation module.Patient injury could occur.Warning frequently assess the patient and monitor any alarm conditions.Failure to do so could result in patient injury.Patient monitoring - the user of the medical device is responsible for choosing a suitable patient monitoring system that provides appropriate information on medical device performance and patient condition.Patient safety can be achieved by a wide variety of means ranging from electronic surveillance of medical device performance and patient condition to direct observation of clinical signs.The responsibility for selecting the best level of patient monitoring lies solely with the user of the medical device.

Event Description

It was reported that 2-3 hours with baby saturation wasn't good, no alarm, no more oxygen.

• Brand Name: RESUSCITIARE RADIANT WARMER
• Type of Device: INFANT RADIANT WARMER
• Manufacturer (Section D): DRAEGER MEDICAL SYSTEMS, INC.; 3135 quarry road; telford PA 18969
• MDR Report Key: 8861956
• MDR Text Key: 153365994
• Report Number: 2510954-2019-00001
• Device Sequence Number: 1
• Product Code: FMT
• Combination Product (y/n): N
• PMA/PMN Number: K120642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1