PortableConnect 10100Recalls & reported problems
Rom Technologies, Inc · The PortableConnect System is a rehabilitative exercise therapy device to increase range of motion · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00860002828718), received between Jan 23, 2026 and Apr 17, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Material Integrity Problem” (2 reports).
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.
Reports received per month
Most reported problems
Device problems
- Material Integrity Problem2
- Application Program Problem: Parameter Calculation Error1
- Computer Software Problem1
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Atrial Fibrillation1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 17, 2026Computer Software Problem; Application Program Problem: Parameter Calculation Error
PATIENT WAS ABLE TO START REHAB ON HER OWN WITHOUT A CARDIAC REHAB SPECIALIST CALL. PATIENT WAS ABLE TO PEDAL FOR 19 MINUTES UNSUPERVISED. CARDIAC REHAB SPECIALIST CALLED AND CONNECTED WITH PATIENT, HE STOPPED EXERCISE AS SHE REPORTED 9/10 SHORTNESS OF BREATH. SHE WAS ALLOWED TO SIT AND REST FOR A BIT. SYMPTOMS DID NOT IMPROVE. PATIENT'S PHYSICIAN WAS CALLED AT 4:18PM CST AND WAS LET KNOW OF THE SITUATION, HE RECOMMENDED THAT EMS BE SENT TO THE PATIENTS HOME. THE PATIENT DID NOT RECEIVE TREATMENT FOR ANY LIFE-THREATENING CONDITION AND ANY IMPAIRMENT WAS PREVENTED BASED ON PATIENT'S RELEASE FROM THE HOSPITAL WITHOUT ADMISSION. THIS WAS THE RESULT OF A SOFTWARE BUG THAT ALLOWED THE FIELD "NO_SESSION_ALLOWED_WITHOUT_CALL" BEING SET TO NULL. THE ISSUE WAS FIXED THE SAME DAY AS THE INCIDENT WITH A SOFTWARE UPDATE, AND ADDITIONAL PROTECTIONS ARE BEING ADDED AT THE DATABASE, API, TESTING, AND MONITORING LEVELS.
Patient problems: Atrial Fibrillation
MAUDE report 24913522 ↗MalfunctionMar 26, 2026Material Integrity Problem
POWER CORD WRAPPED AROUND THE PEDALS AND IS NOW FRAYED, EXPOSING THE CONDUCTORS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24705009 ↗MalfunctionMar 26, 2026Material Integrity Problem
THE POWER CORD GOT TANGLED IN THE PEDALS AND WAS BROKEN, EXPOSING CONDUCTORS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24703899 ↗MalfunctionJan 23, 2026Material Split, Cut or Torn
IT WAS REPORTED THAT THE POWER CORD WRAPPED AROUND THE PEDAL AND BROKE, EXPOSING CONDUCTORS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24168025 ↗
Other System, Isokinetic Testing And Evaluation devices
- Actiwatch Actiwatch Spectrum PlusRespironics, Inc. · SYSTEM, ISOKINETIC TESTING AND EVALUATION2 reports
- Harmony SHR™ M1-00001Harmonic Bionics, Inc. · System, Isokinetic Testing And Evaluation1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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