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

Catalog Number 6487800

Device Problem Human-Device Interface Problem (2949)

Patient Problems Low Oxygen Saturation (2477); Decreased Respiratory Rate (2485); Diminished Pulse Pressure (2606)

Event Date 07/13/2015

Event Type  Injury  

Manufacturer Narrative

Further information regarding the event has been sought.A supplemental medwatch report will be submitted when the investigation is completed.

Event Description

A facility medsun medwatch report was received that stated that: during the admission process the patient was connected to the bedside ventilator by the rt (respiratory therapist).The ventilator settings were confirmed but not accepted, and the ventilator remained in standby mode.Several minutes later, the patient blood pressure dropped unexpectedly, followed by a drop in heart rate (to 30 bpm), and declining oxygen saturation.Nursing adjusted inotrope and vasopressor infusions.While titrating iv drips.The rn (registered nurse) noticed the standby message on the ventilator screen and noted that the patient was not being ventilated, at which point she turned on the ventilator.The patient quickly responded to ventilation and medications, and was successfully intubated later that afternoon.The final patient outcome was no injury.(b)(4).

Manufacturer Narrative

Additional information that was received from the hospital stated, the therapist entered the ventilator parameters and left it in the standby mode.The nursing staff was performing an ekg so the monitor was covered, and as a result, the desaturation was not picked up immediately.It was unknown how long the ventilator was in the standby mode.The ventilator was not pulled out of service.On discovery, ventilation was simply started whereas, the ventilator functioned normally and the patient¿s saturation values rose and returned to normal.The hospital raised 3 issues in regards to the ventilator system with software version 6.0: the claim of insensitivity of the screen cannot be confirmed.The standby screen can be partly covered as reported but, only when another window is opened.This action is operator-initiated and has to be completed or cancelled.As soon as completion is done by accepting or, the action is cancelled, the standby window is bare and clearly visible.The blinking standby red text in software version 7.0 with a black background clearly breaks the monotony that was raised by the hospital.It alerts the user that the patient is not ventilated.Our conclusion is that there was no ventilator malfunction at the time.The ventilator was left in the standby mode.This was the root cause for the event.(b)(4).

Event Description

(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: 5191940
• MDR Text Key: 29972002
• Report Number: 8010042-2015-01052
• 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: Initial,Followup
• Report Date: 10/29/2015,10/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 6487800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/29/2015
• Distributor Facility Aware Date: 10/05/2015
• Device Age: YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/05/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/30/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/01/2016
• 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 Outcome(s): Other
• Patient Age: 71 YR