MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC. (PNC)RESUSCITAIRE RW82/WBR82INFANT RADIANT WARMER

Model Number RW82

Event Date 01/03/2008

Event Type  Injury   Patient Outcome  Required Intervention

Manufacturer Narrative

The customer has not allowed draeger to inspect the device. It was reported that the unit was being used in the manual heating mode. In this mode, the user should constantly observe the infant, and monitor the infant temperature to avoid over heating or under heating. The device is designed so that when in manual mode if the warmer is in operation for longer than 10 mins, the check pt indicator illuminates and the alarm sounds. The indicator remains illuminated, and the alarm continues to sound every 30 seconds for 5 mins or until the user acknowledges the alarm. If the alarm has not been acknowledged for a total of 15 mins, the heater will shut off and a three level alarm sounds continuously. The user must acknowledge this alarm to restart the heater output. The investigation has not determined any product malfunction. The reported pt injury may potentially be due to user error.

Event Description

It was reported that: a nine month old baby was placed in a rw82 for about 30 mins using the manual mode. During this time, the baby was slightly burned.

• Brand Name: RESUSCITAIRE RW82/WBR82
• Type of Device: INFANT RADIANT WARMER
• Manufacturer (Section F): DRAEGER MEDICAL SYSTEMS, INC. (PNC); na
• Manufacturer (Section D): DRAEGER MEDICAL SYSTEMS, INC. (PNC); na
• Manufacturer Contact: gale winarsky ; 3135 quarry rd.; telford , PA 18969; (215) 660 -2239
• Device Event Key: 966260
• MDR Report Key: 996580
• Event Key: 955669
• Report Number: 2510954-2008-00001
• Device Sequence Number: 1
• Product Code: FMT
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: NOT APPLICABLE
• Type of Report: Initial
• Report Date: 02/08/2008

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 02/08/2008
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: Health Professional
• Device MODEL Number: RW82
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: No
• Was The Report Sent To Manufacturer?: No
• Date Manufacturer Received: 01/09/2008
• Was Device Evaluated By Manufacturer?: No
• Date Device Manufactured: 09/01/1996
• Is this a Reprocessed and Reused Single-Use Device?: No
• Is the Device an Implant?: No

Is this an Explanted Device?

• Type of Device Usage: Unkown

Patient TREATMENT DATA

Date Received: 02/08/2008 Patient Sequence Number: 1

#	Treatment	Treatment Date
UNK