NA 11150Recalls & reported problems
Physio-Control, Inc. · PACKAGED - CODE MANAGEMENT MODULE, WI-FI AND CO2 · Class 1
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00883873892107), received between Jun 12, 2019 and Jun 12, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Failure to Analyze Signal” (1 report).
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
Device problems
- Failure to Analyze Signal1
Patient problems
- No Patient Involvement1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 12, 2019Failure to Analyze Signal; Failure to Analyze Signal
THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEY HAVE MULTIPLE DEVICES THAT ARE NOT CORRECTLY IDENTIFYING SHOCKABLE RHYTHMS AS SHOCKABLE. AS A RESULT, DEFIBRILLATION THERAPY MAY NOT BE AVAILABLE TO A PATIENT, IF IT WAS NEEDED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT. PHYSIO-CONTROL CONTACTED THE CUSTOMER TO REQUEST ADDITIONAL INFORMATION ON THE DEVICES AND THE EVENTS. NO RESPONSE HAS BEEN RECEIVED FROM THE CUSTOMER.
Patient problems: No Patient Involvement
MAUDE report 8691496 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.