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المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
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NCMDR Recall
| Reference Number: |
mdprc 157 06 12 000 |
| Date submitted: |
6/27/2012 |
| Manufacturer: | Philips Healthcare |
| Device Type: | Defibrillators, External, HeartStart MRx Monitor/Defibrillators |
| Description: | Defibrillator, External |
| Medical Device Identifier: | Model numbers: M3535A, M3536A, M3536M4, M3536M5, and M3536M6
serial numbers:
US00210180, US00210183, US00210738, US00211000, US00213281
US00214706, US00316827, US00318163, US00319241, US00328491
US00329811, US00333101, US00536832, US00538140, US00543161
US00543825, US00544081, US00544214, US00546107, US00548046
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| Reason of Field Safety Corrective Action: |
In automatic external defibrillator (AED) mode, the MRx may have difficulty interpreting the pads ECG waveform. The MRx may incorrectly analyze the rhythm or may fail to analyze the rhythm.
• In manual defibrillation mode, if the pads/paddles ECG signal is viewed, the user may have trouble interpreting the pads/paddles ECG waveform and determining whether or not to deliver therapy.
• When using Q-CPR Measurement and Feedback, the feedback on ventilation rate may be inaccurate.
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| Remedy Action: |
Philips representative will be contacting you to schedule the installation of updated PCAs in all affected devices.
(user instruction attached)
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| Athorized Representative/Importer/Distributor: | Al-Faisaliah Medical System, Riyadh, (01)2119948 |
| Report Source: | NCMDR |
| Source Ref. Number: | E2BF7D28D831E |
| SFDA Comments: | SFDA urges all hospitals that have devices subjected to recall, to contact the company. |
| Attachments: |  Philips Healthcare.pdf |
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