MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-09 for HEARTSTART MRX M3535A manufactured by Philips Medical Systems.
[69806198]
A follow up report will be submitted once the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[69806199]
The customer reported an unspecified leads error. There was no reported patient involvement.
Patient Sequence No: 1, Text Type: D, B5
[75828232]
The customer reported problem was duplicated by philips service personnel. We are considering that, if the customer required a new cable, they purchased one.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1218950-2017-01557 |
| MDR Report Key | 6390749 |
| Date Received | 2017-03-09 |
| Date of Report | 2017-02-16 |
| Date Mfgr Received | 2017-02-16 |
| Device Manufacturer Date | 2016-10-20 |
| Date Added to Maude | 2017-03-09 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. BETTY HARRIS |
| Manufacturer Street | 3000 MINUTEMAN ROAD |
| 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 |
| Generic Name | DSA |
| Product Code | DSA |
| Date Received | 2017-03-09 |
| Model Number | M3535A |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Address | 3000 MINUTEMAN ROAD ANDOVER MA 01810 US 01810 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-09 |