MAUDE Adverse Event Report: STORZ MEDICAL AG D-ACTOR 100; RADIAL SHOCKWAVE DEVICE

Model Number 23300

Device Problem Fire (1245)

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

Event Date 07/25/2023

Event Type  malfunction  

Manufacturer Narrative

The extracorporeal shock wave therapy system can optionally be equipped and operated by a commercial tablet pc (windowtab10); article number: 26200.0001; 26200.0002).Storz medical is not the legal manufacturer of this tablet pc.The manufacturer of the tablet pc is technikware gmbh & co ks (austria).The tablet (bearing its own ce mark) and the iec 60601-1 approved smpsu for charging the tablet are regarded as me system components.The shock wave system communicates with the tablet via usb cable connection.A first inspection by storz medical indicated that the incident was caused by a lithium battery fire.After consultation with the manufacturer of said tablet pc, this is the first time that one of their tablet pcs caught fire.The tablet is in transit to its manufacturer who will conduct the necessary investigations and provide a report on the results.This report will be used by storz medical to inform decision making regarding further actions.

Event Description

During a treatment session, the tablet suddenly caught fire.There was no injury to the patient, user or third person.

Manufacturer Narrative

The extracorporeal shock wave therapy system can optionally be equipped and operated by a commercial tablet pc (windowtab10); article number: 26200.0001; 26200.0002).Storz medical is not the legal manufacturer of this tablet pc.The manufacturer of the tablet pc is technikware gmbh & co ks (austria).The tablet (bearing its own ce mark) and the iec 60601-1 approved smpsu for charging the tablet are regarded as me system components.The shock wave system communicates with the tablet via usb cable connection.A first inspection by storz medical indicated that the incident was caused by a lithium battery fire.After consultation with the manufacturer of said tablet pc, this is the first time that one of their tablet pcs caught fire.The tablet is in transit to its manufacturer who will conduct the necessary investigations and provide a report on the results.This report will be used by storz medical to inform decision making regarding further actions.9/19/2023 update update 2023-09-08: the manufacturer of the tablet has completed the investigations.Accordingly, the improper use or handling by the user in combination with a worn lithium ion battery are considered the most likely root causes.Reading of the tablet`s log files indicated that (1) the tablet has been shut down 245x by pressing and holding the power button; (2) the tablet has been operated with continuous power supply (the ifu states: "only leave the power supply unit connected to the mains socket until your tablet is completely charged.Always unplug the power adapter from the power outlet after use"; (3) the battery has provided the device with energy for ~7.5 years (tablet operating hours (total uptime) ~40,000 hours.

Event Description

During a treatment session, the tablet suddenly caught fire.There was no injury to the patient, user or third person.

• Brand Name: D-ACTOR 100
• Type of Device: RADIAL SHOCKWAVE DEVICE
• Manufacturer (Section D): STORZ MEDICAL AG; lohstampfesstrasse 8; taegerwilen, 8274 ; SZ 8274
• Manufacturer (Section G): STORZ MEDICAL AG; lohstampfesstrasse 8; taegerwilen, 8274 ; SZ 8274
• Manufacturer Contact: devonne pavlak ; 1000 cobb place blvd; building 400 suite 450; kennesaw, GA 30144 ; 6785817255
• MDR Report Key: 17622560
• MDR Text Key: 321930578
• Report Number: 9613347-2023-00010
• Device Sequence Number: 1
• Product Code: ISA
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K173692
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/25/2023

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 Model Number: 23300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/25/2023
• Initial Date FDA Received: 08/25/2023
• Supplement Dates Manufacturer Received: 07/25/2023
• Supplement Dates FDA Received: 09/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2015
• 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