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 2020-03-10 for AUTOPULSE? RESUSCITATION MODEL 100 8700-0740-11 manufactured by Zoll Circulation Inc.
[188219605]
The customer reported complaint for the platform displaying an error message "analyzing patient size" and a fault 08 (motor controller fault detected) was confirmed during archive review and initial functional testing. The root cause was due to a defective drive train motor. Unrelated to the reported complaint, a damaged load plate cover was observed during visual inspection. The load plate cover needs a replacement to address the issue. This type of physical damage found during visual inspection is characteristic of user mishandling. The autopulse platform failed initial functional testing due to fault 08 (motor controller fault detected) displayed upon powering on. The motor controller's built-in fault detection system signals a fault due to defective drive train motor. The drive train motor was replaced to remedy the fault 08 error message. Review of the archive data indicated multiple fault 08 error messages on the customer reported event date. The load cell characterization test confirmed both load cell modules are functioning within the specification. Following the repair, the autopulse platform was subjected to the run-in test using the 95% patient large resuscitation test fixture (lrtf) without any fault or error. Historical complaints were reviewed for service information related to the reported complaint and there were no similar complaints reported for autopulse platform sn (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[188219606]
During a shift check, the autopulse platform (sn (b)(4)) displayed the user advisory (ua) 45 (not at "home" position after power-on/restart) error message. The customer was able to clear the error, however, the platform displayed "analyzing patient size" and a fault (ua) 08 (motor controller fault detected) after the restart. The customer was unable to clear the errors. No patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010617000-2020-00235 |
| MDR Report Key | 9814288 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-10 |
| Date of Report | 2020-03-10 |
| Date of Event | 2020-02-14 |
| Date Mfgr Received | 2020-02-14 |
| Device Manufacturer Date | 2016-06-29 |
| 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 |
| 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 Phone | 5411030 |
| Manufacturer G1 | ZOLL CIRCULATION INC |
| Manufacturer Street | 2000 RINGWOOD AVENUE |
| 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 | 2020-03-10 |
| Returned To Mfg | 2020-02-25 |
| Model Number | MODEL 100 |
| Catalog Number | 8700-0740-11 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZOLL CIRCULATION INC |
| Manufacturer Address | 2000 RINGWOOD AVENUE SAN JOSE, CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-10 |