| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01275-1 |
| Product Name/Description |
Philips HeartStart MRx Monitor/Defibrillator
Model Number: M3536A
Serial Number range: US00100902 to US00576650
ARTG Number: 95661 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
5/12/2014 |
| Responsible Entity |
|
| Reason/Issue |
Issue 1: The MRx can be susceptible to interference from electrical fast transients (EFTs) when connected to AC or DC power, operating with a LAN cable, or operating near a source of EFT interference, which could cause therapy to be delayed or delivered inadvertently.
Issue 2: If a user undertakes certain atypical clinical workflows (ie, when using external paddles for defibrillation or when using the Periodic Clinical Data Transmission (PCDT) option on the MRx), the MRx can exhibit unexpected behaviour. These workflows do not correspond to instructions in the MRx Instructions for Use (IFU) and are not expected to be performed by trained clinicians. In addition, these device behaviours have only been observed during internal testing, and have not been reported during clinical use.
Issue 3: The MRx could stop demand mode pacing due to an ECG leads-off condition when electrode-to-skin contact impedance values are outside design ranges for detection. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
A software upgrade will be implemented for all units affected by one or more of the above issues. Users are advised that they can continue to use their MRx prior to receiving the software upgrade, provided they follow the temporary workaround instructions provided in the customer letter.
This action has been closed out on 23/10/2018 |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |