MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-03-12 for AUTOPULSE? RESUSCITATION MODEL 100 8700-0730-01 manufactured by Zoll Circulation.
[188240343]
The device associated with this complaint has been received, however, the investigation is pending. A follow up report will be filed when the investigation has been completed.
Patient Sequence No: 1, Text Type: N, H10
[188240344]
During shift check, the autopulse platform (sn (b)(4)) displayed user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) error message. Also, one of the head restraint wires worn out. No patient involvement.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 3010617000-2020-00251 |
MDR Report Key | 9824977 |
Report Source | COMPANY REPRESENTATIVE,USER F |
Date Received | 2020-03-12 |
Date of Report | 2020-03-12 |
Date of Event | 2020-02-17 |
Date Mfgr Received | 2020-02-17 |
Device Manufacturer Date | 2011-03-30 |
Date Added to Maude | 2020-03-12 |
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 | BIOMEDICAL ENGINEER |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Manufacturer Contact | MS KIMTHOA NGUYEN |
Manufacturer Street | 2000 RINGWOOD AVE, |
Manufacturer City | SAN JOSE, CA |
Manufacturer Country | US |
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? RESUSCITATION MODEL 100 |
Generic Name | CARDIAC CHEST COMPRESSOR |
Product Code | DRM |
Date Received | 2020-03-12 |
Returned To Mfg | 2020-02-28 |
Model Number | MODEL 100 |
Catalog Number | 8700-0730-01 |
Operator | HEALTH PROFESSIONAL |
Device Availability | R |
Device Eval'ed by Mfgr | N |
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 | 2020-03-12 |