MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,02,05,06 report with the FDA on 2014-03-18 for TRUECPR? TRUECPR? COACHING DEVICE 3309630 manufactured by Physio-control, Inc.
[12041870]
The initial medwatch report indicates: (b)(6) 2013. The initial medwatch report should indicate: (b)(6) 2013. Additional information for supplemental medwatch report: 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
[19591865]
The user did not feel secure using the device, it was difficult to keep reaching the appropriate depth, users felt they had to go too deep to reach the appropriate depth indicated and were afraid that ribs would break, they felt it was not safe to push this hard. Also, the device was reported to continuously move away and the user was afraid that due to the force that had to be applied to reach the appropriate depth, bones would break during resuscitation; especially in thinner patients. After a review of the device data download, it was observed that the device was inappropriately indicating that the compression depth was too shallow. There was patient use associated however, details and the outcome of the patient was not reported.
Patient Sequence No: 1, Text Type: D, B5
[19796866]
(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. 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 | 3015876-2014-00249 |
| MDR Report Key | 3686366 |
| Report Source | 01,02,05,06 |
| Date Received | 2014-03-18 |
| Date of Report | 2014-02-17 |
| Date of Event | 2013-09-01 |
| Date Mfgr Received | 2014-06-24 |
| Device Manufacturer Date | 2013-05-02 |
| Date Added to Maude | 2014-03-18 |
| 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 | 2014-03-18 |
| Model Number | TRUECPR? COACHING DEVICE |
| Catalog Number | 3309630 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2014-03-18 |