MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-11 for AUTOPULSE? PLATFORM RESUSCITATION MODEL 100 8700-0740-04 manufactured by Zoll Circulation.
[188217579]
Zoll has not received the autopulse platform (sn (b)(4)) for investigation. A follow-up report will be submitted when the platform is returned and investigation has been completed.
Patient Sequence No: 1, Text Type: N, H10
[188217580]
The autopulse platform (sn (b)(4)) displayed user advisory (ua) 16 (timeout moving to take-up position) error message. The platform powered off and powered on by itself. The reporter was unable to specify if the issue occurred during shift check or patient use. No consequences or impact to patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010617000-2020-00245 |
| MDR Report Key | 9821168 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-11 |
| Date of Report | 2020-03-11 |
| Date of Event | 2020-02-17 |
| Date Mfgr Received | 2020-02-18 |
| Date Added to Maude | 2020-03-11 |
| 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 | 2020-03-11 |
| Model Number | MODEL 100 |
| Catalog Number | 8700-0740-04 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| 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 | 2020-03-11 |