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

Model Number PACE 203H

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913); No Pacing (3268)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/06/2014

Event Type  malfunction  

Event Description

(b)(4): hospital sent pace 203h external pacemaker back to manufacturer for service with the statement: 'device failed functional & safety test.Device does not generate stimulation pulse.' upon the receipt on (b)(4) 2014 the pacemaker was subject to short and long term testing (72 h in climate chamber, 24 h monitoring of stimulation pulses).The device appeared to be functional.The error could not be reproduced.On (b)(6) 2014 we contacted the biomedical department and inquired for more information.Apparently the pace 203h was used on a patient who was on an external heart-/lung- support system and monitored.An alarm indicated a dysfunction of pace 203h showing an error code which was not remembered any more.Pace 203h was replaced by another external pacemaker.No injury caused by or related to the dysfunction of pace 203h was reported.

• Brand Name: OSYPKA
• 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: 4121928
• MDR Text Key: 4925909
• Report Number: 9681449-2014-00002
• Device Sequence Number: 1
• Product Code: DTE
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K020896
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 07/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PACE 203H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/11/2014
• Initial Date FDA Received: 08/01/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Weight: 78