MAUDE Adverse Event Report: WIPRO GE HEALTHCARE PRIVATE LTD. LULLABY WARMER; WARMER, INFANT RADIANT

Model Number 2041599-001

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Death (1802)

Event Date 08/28/2019

Event Type  Death  

Manufacturer Narrative

Ge healthcare's investigation into the reported occurrence is ongoing.A follow-up report will be issued when the investigation has been completed.Patient information could not be obtained due to country privacy laws.The initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.Device evaluation anticipated, but not yet begun.

Event Description

The hospital reported that the patient received burns due to prolonged exposure to high heat of the warmer.The patient passed away.

Manufacturer Narrative

The reporting facility's service vendor performed a full checkout of the system and confirmed that the unit is fully functional.Additionally, ge healthcare (gehc) product engineering performed an investigation of this event.The engineering team reviewed the design, materials, manufacturing, service, use, and environmental factors of the lullaby warmer to identify any potential defects that could have led to overheating, assuming that the device was used in manual mode.The clinical cause of death is unknown due to lack of information.The potential device contribution to the alleged patient burns was investigated.The investigation concluded that after 2 hours of constant heater use on an infant in manual mode, the temperature rise would have been gradual and would only have raised the skin temperature of the infant to 38.6 deg c.Good clinical practices require an infant in a warmer to be frequently monitored.From the available information in this case, the investigation concluded that the infant was kept on manual mode (not recommended for prolonged therapy) without a patient temperature probe.The alarms were ringing, and were either completely unattended to or silenced multiple times without checking on the patient (as it was reported that the alarms were ringing on the device when the patient was ultimately attended to).Gehc did request permission to visit the incident site to gather additional information but these efforts were unsuccessful.The site has confirmed that the incident is not a product related issue.Since there is no indication that the device contributed to the issue, no further action is indicated.

• Brand Name: LULLABY WARMER
• Type of Device: WARMER, INFANT RADIANT
• Manufacturer (Section D): WIPRO GE HEALTHCARE PRIVATE LTD.; 4, kadugodi industrial area,; bangalore 56006 7; IN 560067
• MDR Report Key: 9100310
• MDR Text Key: 159427963
• Report Number: 9617277-2019-00003
• Device Sequence Number: 1
• Product Code: FMT
• Combination Product (y/n): N
• PMA/PMN Number: K121625
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 01/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2041599-001
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death