MAUDE Adverse Event Report: SENSORONICS INCORPORATED SENSORONICS; CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)

Model Number SECG-PHP3L-TC1669

Device Problems Overheating of Device (1437); Improper or Incorrect Procedure or Method (2017)

Patient Problem Burn, Thermal (2530)

Event Date 08/22/2020

Event Type  malfunction  

Event Description

Mother of patient notified this navigator during a care call that she would like to file a formal complaint regarding a burn patient attained on her right upper back while sleeping on top of a medical device in patient room on [date redacted].Mother of patient stated, "i first noticed it on [date redacted] when i was giving bath to the patient and i immediately notified the nurse.Her skin was clean on [date redacted]." mother of patient stated, "[redacted] the size of the burn is the same size of the 'connector'." mother of patient clarified that she did not know the name of the medical device.Mother of patient stated, "when i told the nurse she said to me that this 'connector' does become hot at times." mother of patient stated, "if i would have known this i would watched [the patient] and would not have let [the patient] sleep on it." mother of patient stated, "she [patient] has neutropenia so this is something the doctors should have seen right away." mother of patient stated, "i spoke to her medical team and no one followed up with me about the device." patient ask: mother of patient stated, "i want them to do something so this never happens again to anyone else.They need to check this 'connector' and why it is getting hot." mother of patient stated, "they need to inform parents about the connector and make some actions." mother of patient stated she would like to know what actions will be taken to make sure this does not happen again.

• Brand Name: SENSORONICS
• Type of Device: CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)
• Manufacturer (Section D): SENSORONICS INCORPORATED; 40651 calle bandido; murrieta CA 92562
• MDR Report Key: 10755081
• MDR Text Key: 213669988
• Report Number: 10755081
• Device Sequence Number: 1
• Product Code: DSA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: SECG-PHP3L-TC1669
• Device Catalogue Number: SECG-PHP3L-TC1669
• Device Lot Number: M1671A
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/01/2020
• Event Location: Hospital
• Date Report to Manufacturer: 10/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 1825 DA