SERVO GUARD 6595487

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-16 for SERVO GUARD 6595487 manufactured by Maquet Critical Care Ab.

Event Text Entries

[108729958] (b)(4). (b)(6).
Patient Sequence No: 1, Text Type: N, H10

[108729959] It was reported that an alarm indicating high pressure was triggered on a ventilator while it was connected to a patient. A bacteria filter was attached between the patient and the ventilator at the time of the reported event. Once the bacteria filter was removed, the alarm was no longer present. There was no patient harm (b)(4).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 8010042-2018-00243
• MDR Report Key: 7519795
• Date Received: 2018-05-16
• Date of Report: 2018-06-27
• Date Mfgr Received: 2018-05-09
• Date Added to Maude: 2018-05-16
• 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 Street: MAQUET CRITICAL CARE AB R
• Manufacturer City: SOLNA
• Manufacturer Country: SW
• Manufacturer G1: MAGNUS LINDQVIST
• Manufacturer Street: MAQUET CRITICAL CARE AB R
• Manufacturer City: SOLNA
• Manufacturer Country: SW
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: SERVO GUARD
• Generic Name: FILTER, BACTERIAL, BREATHING-CIRCUIT
• Product Code: CAH
• Date Received: 2018-05-16
• Catalog Number: 6595487
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: YR
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MAQUET CRITICAL CARE AB
• Manufacturer Address: SOLNA SW

Patients

Patient Number	Treatment	Outcome	Date
1	0		2018-05-16