MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA PRIMUS; ANESTHESIA UNITS

Catalog Number 8603800

Device Problems Premature Discharge of Battery (1057); Failure to Deliver (2338); Complete Loss of Power (4015); Unexpected Shutdown (4019)

Patient Problem Insufficient Information (4580)

Event Date 11/12/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation was just started.The result will be provided in a follow up report.

Event Description

It was reported that on (b)(6) 2021 after 13.00 during ventilation of a pediatric patient the device switched off.There was an alarm for power supply failure.No injury reported.

Manufacturer Narrative

For the investigation the logfile was analyzed.It was found that at the day of event the device was put into operation after a successful power on self-test.After about 45 minutes a power supply inop-alarm was generated as and the device switched to battery operation as specified.After 3 minutes on battery operation the device generated an alarm that as only 10 % battery-charge was remaining.Just one minute later, the device performed a warm start due to the power disruption, accompanied by a "ventilator failure¿ alarm.The device switched to man/spont mode as specified.In case the battery is fully charged, operation can be continued with the current settings for at least 30 minutes.Obviously, the charging level of the battery decreased faster than expected.As the batteries are subject to an aging process it can be assumed that the identified symptom most likely was caused by an used-up battery.To prevent this, the battery must be replaced every 3 years during product maintenance.Unfortunately, it is not known when the battery was replaced last time so it is not possible to make a statement about the age of the battery.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

It was reported that on (b)(6), 2021 after 13.00 during ventilation of a pediatric patient the device switched off.There was an alarm for power supply failure.No injury reported.

Manufacturer Narrative

Due to a technical issue with our internal emdr system we submitted for the form fda 3500a an incorrect value for the field h3.- not returned to manufacturer.

Event Description

It was reported that on (b)(6) 2021 after 13.00 during ventilation of a pediatric patient the device switched off.There was an alarm for power supply failure.No injury reported.

• Brand Name: PRIMUS
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck ; GM
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 13017353
• MDR Text Key: 284183422
• Report Number: 9611500-2021-00504
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K042607
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8603800
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1