BABYTHERM 8000 WB FR00103

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-27 for BABYTHERM 8000 WB FR00103 manufactured by Dr?gerwerk Ag & Co. Kgaa.

Event Text Entries

[140171324] The investigation has just started; results will be provided within a follow-up report.
Patient Sequence No: 1, Text Type: N, H10

[140171325] It was reported that during transport, particles fell from the heater onto the patient bed. No patient consequences reported.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 9611500-2019-00094
• MDR Report Key: 8455435
• Date Received: 2019-03-27
• Date of Report: 2019-04-26
• Date of Event: 2019-02-22
• Date Mfgr Received: 2019-02-25
• Device Manufacturer Date: 1994-11-30
• Date Added to Maude: 2019-03-27
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MS. SONJA HILLMER
• Manufacturer Street: MOISLINGER ALLEE 53-55
• Manufacturer City: L 23542
• Manufacturer Country: GM
• Manufacturer Postal: 23542
• Manufacturer Phone: 4518822868
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: BABYTHERM 8000 WB
• Generic Name: WARMERS
• Product Code: ILO
• Date Received: 2019-03-27
• Model Number: NA
• Catalog Number: FR00103
• Lot Number: NA
• Device Expiration Date: 2000-01-01
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: DR?GERWERK AG & CO. KGAA
• Manufacturer Address: MOISLINGER ALLEE 53-55 L?BECK 23542 GM 23542

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-03-27