FDA Device

Trio Monitor. Cardiac Monitor (including cardiotachometer and rate alarm).

Hazard

Software anomaly where the variable heart rates may be displayed inaccurately or intermittent 'dashes' may be displayed when the patient's heart rate is derived from ECG.

What You Should Do

Remedy

Letter was sent on 9/24/2004 via FedEx to the three customers with proof of delivery required.

Products

Trio Monitor. Cardiac Monitor (including cardiotachometer and rate alarm).
Brand
Datascope Corp
UPC
Serial Number:  MC02017-I3; MC02134-I3; MC02138-I3; MC02148-I3; MC02321-K3; MC02002-I3; MC02005-I3; MC02006-I3; MC02008-I3; MC02020-I3; MC02023-I3; MC02025-I3; MC02027-I3; MC02030-I3; MC02034-I3; MC02043-I3; MC02044-I3; MC02048-I3; MC02052-I3.

Units Affected

19