MAUDE Adverse Event Report: KARL STORZ SE & CO. KG C-MAC MONITOR; 7 INCH FLAT PANEL MONITOR /C-MAC

Model Number 8403ZX

Device Problem Failure to Power Up (1476)

Patient Problem Death (1802)

Event Date 12/14/2019

Event Type  Death  

Manufacturer Narrative

Per the factory in (b)(4) the power supply unit plug is damaged to a degree that the connection in the plug got interrupted.The led on the power supply indicated the malfunction by not burning, the charge control on the monitor also indicates that the unit is not charging.At the time of the incident most likely the battery was empty.The factory stated there was a defect in the power supply unit and responded internally with a checklist and a future reserve power supply unit.

Event Description

We received a vigilance report from our manufacturer in (b)(4) which was filed with the national competent authority.Allegedly, the power supply unit failed after the first 10 seconds of a intubation.The patient ultimately died.

Manufacturer Narrative

Data in section h6 have been corrected to match the evaluation findings.

Manufacturer Narrative

The primary adaptor of the power supply is bent in two directions.The lock mechanism for the primary adaptor is broken.This led to an interruption of the connection inside.Both - the control led on the power supply itself doesn't work, as well as the charging control led on the monitor.This indicates clear, that there is no charging.Please refer to page 3 item 3 and page 4 item 14, as well as the description on page 4 under "1.1 external systems components", as well as page 15, "5.2 power supply unit".

• Brand Name: C-MAC MONITOR
• Type of Device: 7 INCH FLAT PANEL MONITOR /C-MAC
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, gm,
• Manufacturer (Section G): KARL STORZ SE & CO.KG; dr.-karl-storz -strasse 34; 78532; tuttlingen, gm,
• Manufacturer Contact: susie chen ; 2151 e. grand avenue; el segundo, CA 90245 ; 4242188201
• MDR Report Key: 9611075
• MDR Text Key: 175688896
• Report Number: 9610617-2020-00005
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: B069094
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 8403ZX
• Device Catalogue Number: 8403ZX
• Device Lot Number: NR14617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Death
• Patient Sex: Female