MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA GLOBETROTTER STEPHAN; TRANSPORT INCUBATOR

Model Number GLOBETROTTER IC

Device Problem Smoking (1585)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/05/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation has just started; results will be provided in a follow-up report.

Event Description

It was reported that the device emitted a burning smell.There was no injury reported.

Manufacturer Narrative

A draeger technician went on site to investigate the reported issue.According to the service notification, the fire service had removed the rear of the stephan vent and checked the internal components for any signs of heat related stress/damage, but nothing of the sort was noted.The ventilator reportedly operated as intended.The incubator hood was removed to evaluate the heater plate and no signs of any liquid or substance were observed.The device was reassembled and heated up with no noticeable burning smell or burning odor.The battery box was then removed and it was observed that 1 of 2 batteries was badly swollen and disfigured.Both batteries were only holding 1.3 and 3.9v, respectively, indicating that both were in a deep-discharge state.The batteries were replaced as part of a 2-year service job and proceeded to pass all functional tests before being released to the customer.Additional information was provided and it was confirmed that the reported event occurred during the initial power up of the device (i.E.Prior to patient involvement).The fire alarm was not automatically activated because of smoke detection, but was instead activated by the user.It was also confirmed that the globetrotter stephan was being used for internal hospital transport of patients, as well as external transport, at a rate of 1 to 2 transports per week on average.Furthermore, the customer indicated that the batteries were being inspected yearly and replaced every two years by draeger; however, the site is not performing the battery capacity testing which is required to be performed every 3 months by the user.Of note - the ti500 neonatal transport incubator instructions for use (ifu) indicates that battery life will be reduced by heavier use and depth of discharge.The affected battery in this case was coming due to be replaced as it was reaching two years of age and in deep-discharge.Note that a sealed lead acid (sla) battery, if not maintained properly, can overheat and cause bulging of the plastic casing and an overheated plastic odor (sulfur smell), as reported in this case.Battery failures would be identified during the battery inspection (every year by service personnel) and capacity testing (every 3 months by the user).The following is provided in the ti500 neonatal transport incubator ifu: warning - risk of malfunction - low battery charge can cause the system to shut down prematurely.Always verify the battery life at the recommended time periods listed in the battery maintenance section.Replace the battery if it either fails to meet the performance specifications or meets the recommended replacement period.Note - continued use of the battery adversely affects battery performance and results in more frequent battery replacement.Note - draeger recommends that the incubator remain connected to an ac power source between transports to ensure that the batteries are fully charged.There is no indication of a manufacturing defect or early failure.H3 other text : the device was evaluated on site with no malfunctions identified.

Event Description

It was reported that the device emitted a burning smell.There was no injury reported.

• Brand Name: GLOBETROTTER STEPHAN
• Type of Device: TRANSPORT INCUBATOR
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck ; GM
• Manufacturer (Section G): DRAEGER MEDICAL SYSTEMS, INC; 6 tech drive; andover MA
• MDR Report Key: 14083881
• MDR Text Key: 298631508
• Report Number: 2510954-2022-00001
• Device Sequence Number: 1
• Product Code: FPL
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GLOBETROTTER IC
• Device Catalogue Number: MU20509
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1