FABIUS MRI 8607300

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-03-26 for FABIUS MRI 8607300 manufactured by Dr?gerwerk Ag & Co. Kgaa.

Event Text Entries

[185008098] The investigation is still on-going. The results will be provided within a follow-up report.
Patient Sequence No: 1, Text Type: N, H10

[185008099] It was reported that the tidal vol was not maintained during automatic ventilation at one point during use. Manual ventilation was possible but not auto ventilation, because volume dropped. No injury reported.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 9611500-2020-00096
• MDR Report Key: 9881987
• Report Source: COMPANY REPRESENTATIVE,USER F
• Date Received: 2020-03-26
• Date of Report: 2020-04-03
• Date of Event: 2020-02-12
• Date Mfgr Received: 2020-03-30
• Device Manufacturer Date: 2012-01-31
• Date Added to Maude: 2020-03-26
• 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
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Manufacturer G1: DR
• Manufacturer Street: MOISLINGER ALLEE 53-55
• Manufacturer City: L 23542
• Manufacturer Country: GM
• Manufacturer Postal Code: 23542
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: FABIUS MRI
• Generic Name: ANESTHESIA UNITS
• Product Code: BSZ
• Date Received: 2020-03-26
• Catalog Number: 8607300
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: R
• 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		2020-03-26