MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-03-19 for TRUECPR? TRUECPR? COACHING DEVICE 3309630 manufactured by Physio-control, Inc.
[12131049]
Physio-control has performed additional clinical and engineering analysis of the reported compression depth feedback accuracy issue, and through the course of that investigation has determined that the device is operating within its product requirements and specifications. It was also determined that the current product design meets established user needs and achieves a coaching benefit to the user for delivery of cardiopulmonary resuscitation (cpr) therapy. Physio-control has investigated the reported issue of inaccurate depth measurement and has verified the issue. Physio has determined that the cause of the reported issue is the result of a combination of factors relating to user hand placement and patient anatomy.
Patient Sequence No: 1, Text Type: N, H10
[18568679]
The customer contacted physio-control to report that they didn't feel that their truecpr coaching device provided accurate feedback during a recent patient event. The patient, a (b)(6) male, was found unresponsive on the floor in his home. The patient was down for approximately 20-30 minutes before first responders arrived and began providing treatment. The patient did not respond to acls treatment and was pronounced at the hospital. After a review of the device data download, it was observed that although proper compression depth was being achieved, the device was indicating that the depth was too shallow which would prompt the user to push harder to achieve a deeper compression depth.
Patient Sequence No: 1, Text Type: D, B5
[18768528]
(b)(4). Physio-control has investigated and verified the reported issue. Physio has determined that the cause of the reported issue is due to inaccurate depth measurement displayed by the device as a result of a combination of factors relating to user hand placement and patient anatomy. A physio-control clinical specialist examined the device download as well as the circumstances of the event and concluded that the device use did not likely contribute to the patient outcome, based on the significant patient downtime prior to treatment. Physio-control continues to investigate the reported issue and will submit a supplemental report on this event to the fda as provided by 21 cfr 803. 56.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3015876-2014-00281 |
| MDR Report Key | 3688571 |
| Report Source | 05,06 |
| Date Received | 2014-03-19 |
| Date of Report | 2014-02-17 |
| Date of Event | 2013-06-28 |
| Date Mfgr Received | 2014-06-24 |
| Device Manufacturer Date | 2013-05-13 |
| Date Added to Maude | 2014-03-19 |
| 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 | 0 |
| Event Location | 3 |
| Manufacturer Contact | JASON MARCH |
| Manufacturer Phone | 4258674000 |
| Manufacturer G1 | PHYSIO-CONTROL, INC |
| Manufacturer Street | 11811 WILLOWS ROAD NE PO BOX 97006 |
| Manufacturer City | REDMOND WA 98073970 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 98073 9706 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRUECPR? |
| Generic Name | AID, CARDIOPULMONARY RESUSCITATION |
| Product Code | LIX |
| Date Received | 2014-03-19 |
| Returned To Mfg | 2013-07-18 |
| Model Number | TRUECPR? COACHING DEVICE |
| Catalog Number | 3309630 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 10 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHYSIO-CONTROL, INC |
| Manufacturer Address | 11811 WILLOWS ROAD NE PO BOX 97006 REDMOND WA 98073970 US 98073 9706 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-03-19 |