APOLLO 8606500

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 2020-03-31 for APOLLO 8606500 manufactured by Dr?gerwerk Ag & Co. Kgaa.

Event Text Entries

[185975828] The investigation has just started; results will be provided in a follow-up report
Patient Sequence No: 1, Text Type: N, H10

[185975829] It was reported during a case there was a gas and ventilator failure and only manual ventilation was available. There was no patient injury reported.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 9611500-2020-00105
• MDR Report Key: 9905518
• Report Source: COMPANY REPRESENTATIVE,USER F
• Date Received: 2020-03-31
• Date of Report: 2020-03-31
• Date of Event: 2020-03-03
• Date Mfgr Received: 2020-03-16
• Device Manufacturer Date: 2007-06-30
• Date Added to Maude: 2020-03-31
• 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: BIOMEDICAL ENGINEER
• Health Professional: 3
• Initial Report to FDA: 3
• 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: APOLLO
• Generic Name: ANESTHESIA UNITS
• Product Code: BSZ
• Date Received: 2020-03-31
• Model Number: NA
• Catalog Number: 8606500
• Lot Number: NA
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• 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		2020-03-31