MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2016-04-15 for HEARTSTART FR3 989803149941 manufactured by Philips Medical Systems.
[42805650]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[42805651]
It has been reported that during a patient use event when the qcpr meter was in use, the patient's rib cage was pushed too deeply. The user states they followed the instructions for the qcpr meter. The patient survived. There is no allegation of malfunction against the aed device.
Patient Sequence No: 1, Text Type: D, B5
[56047585]
(b)(4). The patient suffered from pectus excavatum prior to the event. The qcpr meter is not manufactured by philips.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3030677-2016-00925 |
| MDR Report Key | 5581574 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2016-04-15 |
| Date of Report | 2016-04-14 |
| Date Mfgr Received | 2016-04-14 |
| Device Manufacturer Date | 2014-12-01 |
| Date Added to Maude | 2016-04-15 |
| 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 |
| Reporter Occupation | EMERGENCY MEDICAL TECHNICIAN |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. DANA TACKETT |
| Manufacturer Street | 22100 BOTHELL EVERETT HWY |
| Manufacturer City | BOTHELL WA 980218431 |
| Manufacturer Country | US |
| Manufacturer Postal | 980218431 |
| Manufacturer G1 | PHILIPS HEALTHCARE - BOTHELL |
| Manufacturer Street | 22100 BOTHELL-EVERETT HWY BLDG A |
| Manufacturer City | BOTHELL WA 98021 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 98021 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEARTSTART FR3 |
| Generic Name | CPR METER |
| Product Code | LIX |
| Date Received | 2016-04-15 |
| Model Number | 989803149941 |
| Lot Number | 8011420821 |
| ID Number | SEE H10 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Address | 22100 BOTHELL EVERETT HWY BOTHELL WA 980218431 US 980218431 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-04-15 |