MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB SERVO GUARD

Catalog Number 6595487

Device Problem Complete Blockage (1094)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/26/2014

Event Type  malfunction  

Event Description

It was reported that while the ventilator was connected to a pt, the pt was having difficulty to fully exhale.The problem was solved by exchanging the filter that was in the pt circuit and replacing it with a new one.The filter in question had been in use for approximately 14 hrs according to the clinician.A humidifier was also connected in the pt circuit.There was no pt harm.(b)(4).

Manufacturer Narrative

Our field service engineer who was on site observed that there was a large amount of condensed water in the filter body and that the water trap was approximately 1/3 full to the bottom of the filter element.The ventilator that was used at the time could not be located by the hosp; therefore, the logs were not downloaded and the filter was not returned.The investigation therefore consists only of an eval the complaint info and the answers received.The experienced problem indicates increased resistance in the pt circuit leading to the reported exhaling difficulty.The exchange of the filter indicates that the filter had clogged and therefore caused the increased resistance in the pt circuit.There was active humidification which explains the wetness of the filter and the water in the water trap.The filter is specified for use for a maximum of 24 hrs.With lack of the logs we cannot estimate the time the filter was in use, therefore, the reported 14 hrs cannot be confirmed, but as nothing else was exchanged apart from the filter, the cause was most probably a clogged filter.(b)(4).

• Brand Name: SERVO GUARD
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; solna ; SW
• Manufacturer (Section G): MAQUET CRITICAL CARE AB; solna S-17 154; SW S-17154
• Manufacturer Contact: janice pevide ; 45 barbour pond dr; wayne, NJ 07470 ; 9737097753
• MDR Report Key: 3815982
• MDR Text Key: 4452592
• Report Number: 8010042-2014-00121
• Device Sequence Number: 1
• Product Code: CAH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K030071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/28/2014,02/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6595487
• Device Lot Number: 1351
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/26/2014
• Event Location: Hospital
• Date Report to Manufacturer: 03/05/2014
• Initial Date Manufacturer Received: 02/26/2014
• Initial Date FDA Received: 03/28/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1