MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA RH 600; WARMERS

Catalog Number FR00103

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/22/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during transport, particles fell from the heater onto the patient bed.No patient consequences reported.

Manufacturer Narrative

The reported information and photographs provided the basis for the investigation.It was found that the device in question was a dräger rh600 radiant heater and not a babytherm 8000wb as reported.The device was produced in 1994.Since 2010 the end of life of the rh600 has been reached, so it is no longer supported in service.Within the analysis, it could be confirmed that the isolation tubes were disintegrating.If isolation materials are thermally or mechanically damaged, electrical short-circuits can occur and damaged isolation material can fall on patients underneath.The hoses used for isolation are subject to high thermal stress and should therefore be checked visually on a regular basis.If the hoses are faulty, they should be replaced.As product support is no longer provided, it is not possible to replace original components and the device should therefore be completely shut down.The rh600 is not designed or approved for patient transport.No similar cases are known.

Event Description

Please refer to the initial-report.

• Brand Name: RH 600
• Type of Device: WARMERS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 8455435
• MDR Text Key: 140171324
• Report Number: 9611500-2019-00094
• Device Sequence Number: 1
• Product Code: ILO
• Combination Product (y/n): N
• PMA/PMN Number: K945467
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 04/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2000
• Device Catalogue Number: FR00103
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1