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

Catalog Number 8607500

Device Problems Gas Output Problem (1266); Failure to Deliver (2338); Complete Loss of Power (4015); Unexpected Shutdown (4019)

Patient Problem Insufficient Information (4580)

Event Date 06/14/2022

Event Type  malfunction  

Event Description

It was reported that on (b)(6) 2022 at 9:58 am a power failure suddenly occurred during use and the power turned off.

Manufacturer Narrative

The investigation was just started.The results will be forwarded in a follow up report.

Event Description

It was reported that on (b)(6) 2022 at 9:58 am a power failure suddenly occurred during use and the power turned off.

Manufacturer Narrative

For the investigation the logfile was analysed.The logfile shows that the operation was started after a successful selftest.After about one hour of operation a mains power failure occured while the device was operated in man/spont.The device alarmed "power failure" and switched over to battery mode as specified.Two minutes later a battery low warning (<10%) was given, shortly afterwards the device performed a restart and alarmed "ventilator fail".Ventilation in man/spont remains available.In case of a fully charged battery, operation can be continued in the case of a mains power failure for at least 30 minutes.However, the batteries are subject to an aging process and have to be replaced periodically during product maintenance (each 3 years).The used battery set was discharged in a very short time, therefore it was assumed that the battery was used up.A detailed investigation was not possible as no parts were available for the investigation.Also the information when the last service was performed was not provided.Based on the available information the reported switching off of the device was caused by a used up backup battery after a mains power failure.There is no quality problem with early failures of this batteries known.

• Brand Name: PRIMUS INFINITY EMPOWERED
• 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: 14883239
• MDR Text Key: 300782355
• Report Number: 9611500-2022-00126
• 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
• Type of Report: Initial,Followup
• Report Date: 08/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8607500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/31/2013
• 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