MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-04-24 for HEARTSTART MRX M3535A manufactured by Philips Medical Systems.
[4400086]
The customer reported that the ecg connector was worn and that there was intermittent loss of contact with the trunk cable. There was no report of pt involvement.
Patient Sequence No: 1, Text Type: D, B5
[11787562]
Pr#: (b)(4). A follow up report will be submitted upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1218950-2014-02286 |
| MDR Report Key | 3815301 |
| Report Source | 06 |
| Date Received | 2014-04-24 |
| Date of Report | 2014-03-26 |
| Date Mfgr Received | 2014-03-26 |
| Device Manufacturer Date | 2012-01-01 |
| Date Added to Maude | 2014-06-17 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | GREG THEOKAS |
| Manufacturer Street | 3000 MINUTEMAN RD. |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal | 01810 |
| Manufacturer Phone | 9786871501 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEARTSTART MRX |
| Product Code | MJK |
| Date Received | 2014-04-24 |
| Model Number | M3535A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Address | 3000 MINUTEMAN RD. ANDOVER MA 01810 US 01810 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-04-24 |