MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA RADIANT HEATER RH 600; WARMERS, RADIANT, INFANT, MOBILE

Catalog Number 2M20112

Device Problem Device Fell (4014)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/05/2018

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 at 4:30 pm the radiant heater rh 600 of the resuscitation unit pp 8000 fell down.No injury was reported.

Manufacturer Narrative

The affected device was examined by the dräger service on site.The heater rh600 is attached to the traverse of the pp 8000 with four screws.The screws are secured with loctite (screw locking adhesive) and the mechanical fastening of the heater is checked twice a year during the inspection.All four mounting screws were still present on the device.The threads of the screws showed no damage and a test has shown that the screws were still fully functional.Since no damage was detectable, a strong mechanical load can be excluded as a cause.Furthermore, all four screws must have loosened simultaneously because no single screw was damaged or bent.The investigation revealed no technical cause for the simultaneous loosening of all four mounting screws.No similar incidents were reported within the last 3 years.

Event Description

Please refer to the initial-report.

• Brand Name: RADIANT HEATER RH 600
• Type of Device: WARMERS, RADIANT, INFANT, MOBILE
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 8183632
• MDR Text Key: 131333675
• Report Number: 9611500-2018-00411
• Device Sequence Number: 1
• Product Code: FMT
• Combination Product (y/n): N
• PMA/PMN Number: K953489
• 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: 01/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2018
• 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: 2M20112
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1