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)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/24/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the machine shut down in the middle of the surgery.No injury reported.

Manufacturer Narrative

Based on the analysis of the device log file the case in question could be comprehended.Short after the alarm that the battery capacity underran 10%, the device switched off.Power cycling revealed a battery charge level of 0%.Within the next 45 minutes, the battery was recharged again.Further entries were found pointing to an old battery.The battery is required to be replaced every 3 years during service.As the device was manufactured in 2011, the battery pack should have been replaced in 2020 already.In case of a power supply failure or if main power is not connected, the device continues operation using the internal backup batteries without limitation of functionality while a power failure alarm is given.The remaining capacity of the batteries is indicated to the user and additional warnings are given when the residual battery capacity underruns 20% respectively 10%.The ifu describes that with a fully charged battery operation can be continued with the current settings for at least 30 minutes (with an old battery with different characteristics due to the aging process, this time might be noticeably less).With a warning the user is informed that if the batteries are not sufficient charged and a power failure occurs, it may not be possible to continue operation for long enough.It can be concluded that the reported event probably was caused by an used up backup battery in combination with an unplugged mains power connection.In consequence, the battery was fully discharged in a very short time.

Event Description

It was reported that the machine shut down in the middle of the surgery.No injury reported.

Event Description

It was reported that the machine shut down in the middle of the surgery.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.

• 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: 12127227
• MDR Text Key: 262636332
• Report Number: 9611500-2021-00291
• 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: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 05/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2021
• 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: 08/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2011
• 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