MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB SERVO GUARD; FILTER, BACTERIAL, BREATHING-CIRCUIT

Catalog Number 6671775

Device Problem Increase in Pressure (1491)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/08/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(6) 2015 02:19 pm (gmt-5:00) added by (b)(6) ((b)(4)): further information regarding the event has been sought.A supplemental medwatch report will be submitted when the investigation is completed.

Event Description

It was reported that after replacement of the filter in the patient circuit, it was noted that the peep (positive end expiratory pressure) rose between 24 and 32 cm h2o while the ventilator was connected to a patient.The filter was replaced with another one and the peep went back to the set value of 4 cm h2o.It was further reported that the issue with the high peep occurred immediately after switching out the previous filter with a new filter.Therefore there were no hours of nebulization or humidification involved.There was no patient harm.(b)(4).

Manufacturer Narrative

The investigation of the reported filter has been finalized.During testing in a reference ventilator, the issue could be confirmed.The test indicated a higher peep than set, and a small gas flow through the filter.The visual inspection concluded that there is a plastic membrane in the inlet of the filter blocking the gas flow.If the filter were to be tested before use in the mandatory pre-use checks, the user should be able to identify that the filter is not within specification.

Event Description

(b)(4).

• Brand Name: SERVO GUARD
• Type of Device: FILTER, BACTERIAL, BREATHING-CIRCUIT
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; solna ; SW
• Manufacturer (Section G): MAGNUS LINDQVIST; maquet critical care ab; röntgenvägen 2, se-171 54; solna ; SW
• Manufacturer Contact: maquet critical care ab; röntgenvägen 2, se-171 54; solna
• MDR Report Key: 5262176
• MDR Text Key: 32787611
• Report Number: 8010042-2015-01078
• Device Sequence Number: 1
• Product Code: CAH
• Combination Product (y/n): N
• PMA/PMN Number: K030071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6671775
• Device Lot Number: 2000041290
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Device Age: YR
• Date Manufacturer Received: 11/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1