MAUDE Adverse Event Report: OSYPKA MEDICAL GMBH OSYPKA PACE 203H; PULSE-GENERATOR, PACEMAKER, EXTERNAL

Model Number PACE 203H

Device Problem Battery Problem (2885)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/02/2023

Event Type  malfunction  

Manufacturer Narrative

The device involved in the incident has not been returned to the manufacturer.The healthcare professional reported: that "investigation carried out.No device issues found.All issues were found to be due to faulty duracell plus 6lr61 (pp3) 9 volt batteries.On checking each affected battery the voltage was found to be very low (approx.5 to 6v).After requesting the facility confirmed that: "the problem with the batteries was observed on other devices e.G.Syringe drivers in other locations so we are sure it was a battery batch issue rather than due to the device.This was reported back to our suppliers and the failed batteries were returned to them for inspection.Some were still in sealed packaging." finally it was confirmed that "the device has been back in use since 20/03/2023 and no further problems reported.".

Event Description

It has been reported by the clinical personal: "a post-operative cardiac surgery patient needing external cardiac pacing via an osypka pace 203h pacing box.During use, the pacing box showed low battery.Battery change procedure started which entails live swapping of the battery while the device provides approx.30 seconds (minimum) of internal reserve power.Nurse swapped expired battery for a new(out the packet) duracell plus 6lr61 (pp3) 9 volt.The pacing box did not 'recognise' the new battery.A second new battery was swapped into the pacing box, again the new battery was not 'recognised'.A third new battery was swapped and this time it did work.The nurse swapping the batteries has experience of doing this procedure many times.The pacing box never powered down so the patient came to no harm.If not for the quick intervention of the nurse the patient may have had a cardiac arrest.Similar battery issues experienced recently with other devices.Also, a few weeks ago an entire box of new 9v batteries was found to be not working.".

• Brand Name: OSYPKA PACE 203H
• Type of Device: PULSE-GENERATOR, PACEMAKER, EXTERNAL
• Manufacturer (Section D): OSYPKA MEDICAL GMBH; albert-einstein-strasse 3; berlin, berlin 12489 ; GM 12489
• Manufacturer (Section G): OSYPKA MEDICAL GMBH; albert-einstein-strasse 3; berlin, berlin 12489 ; GM 12489
• Manufacturer Contact: mr. joerg ; falkendamm 20a; berlin, berlin 12489 ; GM 12489
• MDR Report Key: 16945874
• MDR Text Key: 315378662
• Report Number: 9681449-2023-00001
• Device Sequence Number: 1
• Product Code: DTE
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K020896
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 05/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PACE 203H
• Device Catalogue Number: 61225
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2023
• Was Device Evaluated by Manufacturer?: No
• 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 Outcome(s): Other