MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC RESUSCITAIRE RW82/WBR82; RESUSCITAIRE RADIANT WARMER

Catalog Number	MU20503
Medical Device Problem Codes	Fracture (1260); Device Tipped Over (2589)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation has just started, results will be provided in a follow-up report.
Event or Problem Description
It was reported that a caster of the device broke off causing the unit to topple over.There was no patient involved but a nurse was reportedly hit by the device.There was no detail in the report which would reasonably suggest that a serious injury had occurred.
Additional Manufacturer Narrative
A complaint was received involving a resuscitaire caster snapping off, causing the device to fall over and hit a nurse in the head.No patient involvement was reported.Multiple attempts to clarify the event were made without success.It is unknown if the nurse was injured as a result of the event.Pictures provided confirm the damage to the caster stem was caused by a clean break rather than a manufacturing defect.The customer admitted the device was being rushed across a parking lot when the caster broke.Based on the results of the investigation, root cause was identified as user error.Per the instructions for use (ifu), "the resuscitaire is designed for use anywhere labor and delivery may occur within a healthcare facility".The device should not be taken outside the healthcare facility once installed.To resolve the issue, the customer replaced the caster.No further issues have been reported.Per the ifu: warning to prevent injury or damage to the warmer, employ 2 persons of sufficient strength to adequately control the warmer during transport.Use the handle when moving the equipment.Failure to do so could result in personal injury.Warning push or pull the warmer in a straight line along the length of the device.Lateral or angular movement (across the width) can result in inadvertent tip-over if the wheels encounter any obstacle.H3 other text : see h10.
Event or Problem Description
It was reported that a caster of the device broke off causing the unit to topple over.There was no patient involved but a nurse was reportedly hit by the device.There was no detail in the report which would reasonably suggest that a serious injury had occurred.

• Brand Name: RESUSCITAIRE RW82/WBR82
• Common Device Name: RESUSCITAIRE RADIANT WARMER
• Manufacturer (Section D): DRAEGER MEDICAL SYSTEMS, INC; 3135 quarry road; telford PA
• Manufacturer (Section G): DRAEGER MEDICAL SYSTEMS, INC.; 3135 quarry road; telford PA
• Manufacturer Contact: 3135 quarry road; telford, PA ; 2156602400
• MDR Report Key: 18099787
• Report Number: 1220063-2023-00042
• Device Sequence Number: 7863010
• Product Code: FMT
• UDI-Device Identifier: 04049098000215
• UDI-Public: (01)04049098000215(11)170427(17)190427(93)MU20503-50
• Combination Product (Y/N): N
• PMA/510(K) Number: K120642
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: MU20503
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/25/2023
• Supplement Date Received by Manufacturer: 05/17/2024
• Initial Report FDA Received Date: 11/09/2023
• Supplement Report FDA Received Date: 05/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown