MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA SAVINA; VENTILATORS, INTENSIVE CARE

Catalog Number 8414000

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Hyperventilation (1910)

Event Date 10/01/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation is still on-going.The results will be provided within a follow-up report.

Event Description

It was reported that during use on patient, the peep values is not consistent with the set value.The patient was breathing hard.The doctors immediately replaced the device.The patient¿s situation was improved by the use of 40mg of methylprednone intravenous.

Manufacturer Narrative

After the event it was found by the hospital that the flow sensor module was broken.As a disturbance of the expiratory flow measurement may affect all flow derived measurement values like the tidal volume, the minute volume, the flow curve and also the peep measurement as it depends on a flow trigger it can be assumed that a faulty flow sensor probably was root cause for the reported symptom that the peep value was not consistent with the set value.In this case the savina will post a high priority alarm "flow sensor inoperable" audible and visible.Additional alarms are posted if measurement values reach the alarm limits set by the user.It is recommended if not done already to replace the flow sensor.The exact proceeding how to exchange the flow sensor is described in the ifu.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.

Event Description

Please refer to the initial-report.

• Brand Name: SAVINA
• Type of Device: VENTILATORS, INTENSIVE CARE
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck ; GM
• MDR Report Key: 9254535
• MDR Text Key: 177246044
• Report Number: 9611500-2019-00358
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 04048675407881
• UDI-Public: (01)04048675407881(11)170615(93)8414000-36
• Combination Product (y/n): N
• PMA/PMN Number: K003068
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 12/19/2019

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: 8414000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/22/2019
• Initial Date FDA Received: 10/30/2019
• Supplement Dates Manufacturer Received: 12/19/2019
• Supplement Dates FDA Received: 12/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention