N/A Patient Data ModuleRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840682104784), received between Mar 22, 2023 and Mar 22, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Defective Device” (1 report).

13 other recalls cover devices cleared under the same FDA submission (K071073); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 22, 2023Defective Device

  NURSE ATTEMPTED TO TAKE A BLOOD PRESSURE OF A PATIENT AND WAS UNABLE TO. ALSO REPLACED THE CUFF AND THE TUBING WITH THE SAME RESULT SO THE MODULE WAS TAKEN OUT OF SERVICE AND RETURNED TO THE MANUFACTURE FOR A WARRANTY REPAIR. MANUFACTURER RESPONSE FOR MONITOR, PHYSIOLOGICAL, PATIENT (WITH ARRHYTHMIA DETECTION OR ALARMS), GE (PER SITE REPORTER). THEY REPLACED THE MAIN BOARD AND CALIBRATED.

  Patient problems: Insufficient Information

  MAUDE report 16589859 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K071073. One submission often covers many models, so check the product and lot details in each record.

• Z-2139-2021 · May 21, 2021 · Open, Classified
  CARESCAPE PDM-Masimo SpO2. Physiological data monitor.
• Z-2424-2020 · May 18, 2020 · Open, Classified
  CARESCAPE Patient Data Module (PDM) used with the following monitors: CARESCAPE B450/B650/B850, SOLAR 8000M/I and Transport Pro, Model Numbers: 2042084-001 2094504-001 2042084-001-
• Z-0522-2019 · Aug 31, 2018 · Open, Classified
  Solar 8000i Patient Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients.
• Z-0202-2018 · Jul 13, 2017 · Terminated
  CARESCAPE Patient Data Module (PDM) v2.6 software used with CARESCAPE Monitors B850, B650, and B450 v2.0.7 or earlier software The PDM is intended to provide uninterrupted acquisit
• Z-0060-2015 · Sep 19, 2014 · Terminated
  GE Healthcare Carescape Patient Data Module
• Z-1147-2014 · Feb 13, 2014 · Terminated
  GE Healthcare Solar 8000M and Solar 8000i Patient Monitor software version 5.4, 5.5, or 5.6 with the Automatic-View-On- Alarm (AVOA) feature enabled. The Solar 8000i with Patient
• Z-1095-2014 · Jan 27, 2014 · Terminated
  CSI, Diamondback 360 Coronary Orbital Atherectomy System, Part Number 70058-02, Model Number DBEC-125 Product Usage: The system is indicated to facilitate stent delivery in patie
• Z-0648-2014 · Dec 16, 2013 · Terminated
  SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient Data Module)
• Z-0807-2014 · Dec 5, 2013 · Terminated
  SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient Data Module) Product Usage: The Patient Data Module (PDM) is intended to provide
• Z-0747-2014 · Nov 27, 2013 · Terminated
  GE Healthcare Carescape Patient Data Module The Patient Data Module (PDM) is intended to provide uninterrupted acquisition of physiologic parameter data on adult, pediatric and n
• Z-2116-2013 · Apr 3, 2013 · Terminated
  SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient Data Module) Product Usage: The Patient Data Module (PDM) is intended to provid
• Z-0524-2013 · Feb 17, 2012 · Terminated
  GE Healthcare Carescape Patient Data Module with v2.0 software used with Solar 8000M/l, Transport Pro or Carescape B650/B850 host monitor. The Patient Data Module (PDM) is intended
• Z-0363-2011 · Oct 5, 2010 · Terminated
  GE Healthcare Transport Pro Monitor with the CARESCAPE" Patient Data Module.