MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA PERSEUS A500; ANESTHESIA UNITS

Catalog Number PRODUCT PART NO. MK06000

Device Problems No Apparent Adverse Event (3189); Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 02/28/2024

Event Type  malfunction  

Event Description

It was reported that during use on a patient the screen of the anesthesia device flashed, which affected the normal use.The patient was connected to a standby device.No injury or serious impairment of patient´s state of health was reported.

Manufacturer Narrative

The event was reported by the hospital to the national authority only - there was no information or involvement to/of the manufacturer or its national representative.Upon request, no further information could be obtained.Due to the very limited information the manufacturer is not able to conclude if the event was related to a device malfunction or maybe environmental conditions or a use problem.The available information does not allow an investigation and thus, no reliable conclusion in regard to the root cause can be drawn.The device must be operated under constant supervision of a trained user who will immediately recognize the issue.The device design would allow manual ventilation including gas dosage via the built-in breathing bag.The case was closed due to insufficient information.H3 other text : device not available for investigation.

• Brand Name: PERSEUS A500
• 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: 18919903
• MDR Text Key: 337846503
• Report Number: 9611500-2024-00115
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K133886
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PRODUCT PART NO. MK06000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/01/2024
• Initial Date FDA Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: No
• 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