MAUDE report

MAUDE report 20454: HEARTSTART

No Answer Provided · received Jan 19, 1995 · LAERDAL MFG. CORP.

Key facts

MDR report key 20454
Report number MW4000664
Event type No Answer Provided
Brand name HEARTSTART
Model number 200
Manufacturer LAERDAL MFG. CORP.
Product code MKJ
Device class Class III
Date received by FDA Jan 19, 1995
Report date Jan 19, 1995
Report source Maude

At a glance

  • None Device problems coded
  • 1,000+ MAUDE reports for this product code
  • 1,000+ MAUDE reports for this brand
  • 10–99 Death reports for this brand
  • 10–99 Injury reports for this brand
  • No Adverse event flagged
  • Yes Product problem flagged

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About MAUDE medical device reports

MAUDE holds medical device reports (MDRs) of suspected device-associated deaths, serious injuries and malfunctions submitted to the FDA by manufacturers, importers, user facilities and the public. A report alone does not establish that a device caused an event.

Source: U.S. Food and Drug Administration (FDA), MAUDE (Manufacturer and User Facility Device Experience) database · Source date:

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