MAUDE Adverse Event Report: PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC HEARTSTART XL+

Model Number 861290

Device Problem Failure of Device to Self-Test (2937)

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

Event Date 12/08/2021

Event Type  malfunction  

Manufacturer Narrative

This supplemental report was created in reference to manufacturer's report number 3030677-2021-16666 previously submitted and closed.This complaint record was incorrectly created and will be closed / cancelled with no further investigations or reporting.

Event Description

It was reported to philips that etco2 check error message appeared during installation.

• Brand Name: HEARTSTART XL+
• Type of Device: HEARTSTART XL+
• Manufacturer (Section D): PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC; no.2 keji north 3rd road; nanshan district; shenzhen ; CH
• Manufacturer (Section G): PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC; no.2 keji north 3rd road; nanshan district; shenzhen ; CH
• Manufacturer Contact: tara mackinnon ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 13113060
• MDR Text Key: 282958812
• Report Number: 3030677-2021-16690
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K110825
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial

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: 861290
• Device Catalogue Number: 861290
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/08/2021
• Initial Date FDA Received: 12/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1