MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-10 for AUTOPULSE? PLATFORM RESUSCITATION MODEL 100 8700-0730-01 manufactured by Zoll Circulation.
[188220244]
The reported complaint of the autopulse platform (serial (b)(4)) displayed a user advisory - "(ua) 41" (patient temperature sensor failure) error message was not confirmed during functional test and archive data review. The autopulse platform performed as intended. Unrelated to the reported complaint, a cracked bottom enclosure was observed on the returned autopulse platform during visual inspection. This type of physical damage was likely due to mishandling. The cover was replaced. The autopulse platform passed initial functional testing without any fault or error. During archive data review, no record of ua41 (patient temperature sensor failure) or any other significant errors. After minor service repair, the autopulse was subjected to the run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test battery until discharged. The autopulse platform passed all the functional tests.
Patient Sequence No: 1, Text Type: N, H10
[188220245]
During training, the autopulse platform (serial (b)(4)) displayed a user advisory - "(ua) 41" (patient temperature sensor failure) error message when it was powered on. The ua41 could not be cleared by the user. No patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010617000-2020-00237 |
| MDR Report Key | 9814312 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-10 |
| Date of Report | 2020-03-10 |
| Date of Event | 2020-02-12 |
| Date Mfgr Received | 2020-02-14 |
| Device Manufacturer Date | 2014-09-26 |
| Date Added to Maude | 2020-03-10 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. KIM THOA NGUYEN |
| Manufacturer Street | 2000 RINGWOOD AVE, |
| Manufacturer City | SAN JOSE, CA |
| Manufacturer Country | US |
| Manufacturer Phone | 4192922 |
| Manufacturer G1 | ZOLL CIRCULATION |
| Manufacturer Street | 2000 RINGWOOD AVE. |
| Manufacturer City | SAN JOSE, CA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AUTOPULSE? PLATFORM RESUSCITATION |
| Generic Name | CARDIAC CHEST COMPRESSOR |
| Product Code | DRM |
| Date Received | 2020-03-10 |
| Returned To Mfg | 2020-02-24 |
| Model Number | MODEL 100 |
| Catalog Number | 8700-0730-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZOLL CIRCULATION |
| Manufacturer Address | 2000 RINGWOOD AVE. SAN JOSE, CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-10 |