MAUDE Adverse Event Report: OSYPKA MEDICAL GMBH OSCOR; EXTERNAL PACEMAKER

Model Number PACE 203H

Device Problems Failure to Capture (1081); Compatibility Problem (2960)

Patient Problems Bradycardia (1751); Complete Heart Block (2627)

Event Date 01/08/2014

Event Type  malfunction  

Event Description

In 5 patients using the combination of pace 203h external pacemaker and a&e medical pacing wires lead to what the pace 203 interpreted as an electrical short-circuit, stopping stimulation.This problem occurred only when the ventricular output amplitude exceeded about 15 v.This problem was reproducable.Two of the 5 patients were pacemaker-dependent and required intervention.In one case it took reportedly about 25 seconds to dial-back the amplitude and restore stimulation.

Manufacturer Narrative

Evaluation: we suspected that the combined impedance of heartwires and heart tissue located between the electrodes of the pacing wires established a low impedance electrical circuit less than the minimum impedance (200 ohms) specified for the pace 203h.The following graph illustrates the maximum output (in v shown on the y axis) vs.The impedance as seen by the pacemaker.If the user increases the amplitude output is increased beyond this level, the pace 203h's current limiter determines excess currents, terminates stimulation and displays the warning message "short circuit.".

• Brand Name: OSCOR
• Type of Device: EXTERNAL PACEMAKER
• Manufacturer (Section D): OSYPKA MEDICAL GMBH; albert-einstein-strasse 3; berlin 1248 9; GM 12489
• Manufacturer Contact: thilo thuemecke ; albert-einstein-strasse 3; berlin 12489 ; GM 12489 ; 063928300
• MDR Report Key: 3650520
• MDR Text Key: 21730012
• Report Number: 9681449-2014-00001
• Device Sequence Number: 1
• Product Code: DTE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020896
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PACE 203H
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/08/2014
• Initial Date FDA Received: 01/15/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2013
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention