MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2013-04-11 for SONICAID manufactured by Huntleigh Healthcare Ltd. Diagnostics.
[18857461]
(b)(4)
Patient Sequence No: 1, Text Type: D, B5
[19217627]
Arjohuntleigh, inc. Is submitting the report on behalf of huntleigh healthcare ltd. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1000589001-2013-00003 |
| MDR Report Key | 3110552 |
| Report Source | 01 |
| Date Received | 2013-04-11 |
| Date Mfgr Received | 2013-03-20 |
| Device Manufacturer Date | 2009-02-01 |
| Date Added to Maude | 2013-05-16 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | STEVE KAHN |
| Manufacturer Street | 2349 WEST LAKE ST. |
| Manufacturer City | ADDISON IL 60101 |
| Manufacturer Country | US |
| Manufacturer Postal | 60101 |
| Manufacturer Phone | 8003231245 |
| Manufacturer G1 | HUNTLEIGH HEALTHCARE LTD. DIAGNOSTICS |
| Manufacturer Street | 35 PORTMANMOOR RD. |
| Manufacturer City | CARDIFF |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SONICAID |
| Generic Name | FM800 RANGE OF FETAL MONITORS |
| Product Code | HEL |
| Date Received | 2013-04-11 |
| Operator | OTHER |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HUNTLEIGH HEALTHCARE LTD. DIAGNOSTICS |
| Manufacturer Address | 35 PORTMANMOOR RD. CARDIFF |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-04-11 |