MAUDE Adverse Event Report: MICROPORT CRM S.R.L. CPR4; Pacemaker/Icd/Crt Non-Implanted Components

Model Number	CPR4 HEAD
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Reportedly, the subject cpr4 is not recognised by several tablets.

• Brand Name: CPR4
• Common Device Name: Pacemaker/Icd/Crt Non-Implanted Components
• Manufacturer (Section D): MICROPORT CRM S.R.L.; via crescentino s.n; saluggia (vc) 13040 ; IT 13040
• Manufacturer (Section G): MicroPort CRM S.r.l.; via crescentino s.n; saluggia (vc) 13040 ; IT 13040
• Manufacturer Contact: anne rousseau-plasse ; via crescentino s.n; saluggia (vc) 13040 ; IT 13040 ; +33(146)013082
• MDR Report Key: 25528845
• Report Number: 1000165971-2026-00245
• Device Sequence Number: 9175074
• Product Code: OSR
• UDI-Device Identifier: 08031527019611
• UDI-Public: (01)08031527019611
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P980049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2026

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
• Operator of Device: Health Professional
• Device Model Number: CPR4 HEAD
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/17/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/17/2026
• Supplement Report FDA Received Date: 09/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown