MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA ATLAN A350; ANESTHESIA UNITS

Catalog Number 8621500

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 10/04/2023

Event Type  malfunction  

Event Description

It was reported that the atlan failed during a case and that no alarms were given before the power went off.No patient injury reported.

Manufacturer Narrative

Based on the log analysis the device was disconnected from mains at 11:50 on the reported date of event, october 4th 2023.At 13:19:28 the next case was started without reconnecting mains supply.At 14:07:48 the medium priority alarm "battery charge low" was issued indicating that the capacity of the battery dropped to 20%.Three minutes later a high priority "battery charge very low" alarm was posted indicating a residual capacity of 10%.Within the same minute the atlan shut down due to depleted batteries.The atlan ifu describes that the operation is maintained for at least 45 minutes when the battery is fully charged.As this criterion was met the complaint initially was assessed as non-reportable.But in-depth investigation revealed that the technical requirements were partially not fulfilled.In case of a high priority alarm the function must be maintained at least 5 minutes.Based on the log records it can be concluded that this criteria was not met in the current case.Therefore, the case is subsequently assessed as reportable.The reported effect has been assessed by risk management with an acceptable residual risk.

• Brand Name: ATLAN A350
• 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
• Manufacturer Contact: moislinger allee 53-55; lübeck 23542 ; 4518822868
• MDR Report Key: 18854141
• MDR Text Key: 337692903
• Report Number: 9611500-2024-00098
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 04048675556176
• UDI-Public: (01)04048675556176(11)230430(93)8621500-15
• Combination Product (y/n): N
• PMA/PMN Number: K230931
• 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
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8621500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2023
• 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