MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB SERVO-I; VENTILATOR, CONTINUOUS, FACILITY USE

Catalog Number 6487800

Device Problem Device Emits Odor (1425)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/30/2015

Event Type  malfunction  

Manufacturer Narrative

September 18, 2015 04:27 pm (gmt-4:00) added by (b)(6): further information about the event has been sought.A supplemental medwatch report will be submitted when the investigation is completed.

Event Description

A facility medwatch #(b)(4) was received stating that: staff member reports a strong plastic like smell coming from area in the neuro intensive care unit.I also smelled this odor on assessment of issue in this area.Buildings and grounds notified and up to assess issue.After assessment they felt that the odor was coming from the ventilator.(b)(4).

Manufacturer Narrative

According to information received from the customer the ventilator was investigated by the hospital biomedical engineer and no strong plastic smell could be detected.It was found that the filter outside the fan assembly was completely blocked by dust.There was also dust inside the ventilator around the printed circuit boards.The biomedical engineer vacuumed inside the ventilator and cleared the filter of dust.The ventilator was plugged in and successfully passed pre-use check and was run overnight with a test lung without any problems or plastic smell.No investigation has been possible since no parts were replaced and no log files were collected.Our conclusion is that the blocked fan filter and dust inside the ventilator likely may have caused the plastic smell.

Event Description

(b)(4).Facility medsun/medwatch #: (b)(4).

• Brand Name: SERVO-I
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• 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: 5094170
• MDR Text Key: 26654571
• Report Number: 8010042-2015-01001
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• PMA/PMN Number: K123149
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Followup
• Report Date: 08/24/2015

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: 6487800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/22/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/07/2015
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Age: 55 YR