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

Catalog Number 8603800

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

Patient Problem Insufficient Information (4580)

Event Date 05/18/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation has been started, results will be provided with the follow-up report.

Event Description

It was reported that the ventilator failed during use.There was no patient injury reported.

Manufacturer Narrative

Unfortunately, the complete electronic device log was not available, only extractions of the user and info log were provided.Based on this given information however, the reported vent failure could be confirmed.As it was further reported, the batteries were more than 3 years old and a battery replacement flag was set from power supply (¿battery in power supply old¿ entry given).Thus, most likely the reported symptom was caused by a used-up backup battery pack in the device in combination with an unplugged mains power connection.Therefore, the battery pack was totally discharged leading to the reported symptom.Besides, a corresponding power fail warning entry is missing in the logs which should have been logged to detect the missing mains power.In general, in case the device is disconnected from mains power, the operations will be continued using the internal backup batteries, which would be indicated by the ¿power failure¿ alarm, if no power supply failure is present.However, the battery use is still shown by a yellow battery sign in the right upper corner on the display in combination with a % level printed on the screen.On top, the remaining capacity of the batteries is still indicated to the user and additional warnings are given when the residual battery capacity underruns 20% respectively 10%.The device permits manual ventilation with 100 % o2 in the case of a power failure and empty batteries.As the o2 flows through the vaporizer, dosage of anesthetic agent remains possible as well.The batteries are subject to an aging process and are replaced periodically during the product maintenance, each 3 years.There is no quality problem with early failures of this batteries known.As further reported, the batteries of the device in question were from 2017.A replacement of the old batteries as well as precautionary replacement of the power supply was recommended accordingly.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 the ventilator failed during use.There was no patient injury reported.

• Brand Name: PRIMUS
• Type of Device: ANESHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 11963931
• MDR Text Key: 261701013
• Report Number: 9611500-2021-00245
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 04048675041436
• UDI-Public: (01)04048675041436(11)170920(17)180219(93)8603800-93
• Combination Product (y/n): N
• PMA/PMN Number: K042607
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 07/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2021
• 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
• Date Manufacturer Received: 05/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1