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 2020-03-12 for AUTOPULSE? PLATFORM RESUSCITATION MODEL 100 8700-0730-01 manufactured by Zoll Circulation.
[188227825]
The reported complaint of the autopulse platform (sn: (b)(4)) displayed "system error, out of service, revert to manual cpr" error message was confirmed based on review of the archive data and during functional testing. The root cause for the reported complaint was due to a communication error. The reported complaint of "small cracks were observed on the top cover of the platform" was confirmed during visual inspection. The root cause for the observed physical damage was most likely due to normal wear and tear. The autopulse platform was manufactured in december 2012, and it is over 7 years old and has exceeded its expected service life of 5 years. Visual inspection of the returned platform revealed small cracks on the top cover; thus, confirming the reported complaint. The top cover was replaced to remedy the damage. The archive data review showed occurrence of system error ua132 (internal watchdog timeout) on the customer reported event date; thus, confirming the reported complaint. The autopulse platform failed initial functional testing due to "system error, out of service, revert to manual cpr" error message displayed upon powering up the device. Therefore, the reported complaint was confirmed. The platform was connected to the autopulse vision software to clear the system error ua132. Following service, including deburring of the clutch plate, the autopulse was subjected to the run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test batteries until discharged without any fault or error. The brake gap inspection was performed and verified the brake gap was within the specification. Load cell characterization test was performed and confirmed both cell modules are functioning within the specification. Historical complaints were reviewed for service information related to the reported complaint, and there was no previous history of complaint reported for autopulse with serial number (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[188227826]
The autopulse platform (sn: (b)(4) displayed "system error, out of service, revert to manual cpr" error message. Also, small cracks were observed on the top cover of the platform. It is unknown whether the error occurred during shift check or patient use. No consequences or impact to patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010617000-2020-00241 |
| MDR Report Key | 9826529 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-12 |
| Date of Report | 2020-03-12 |
| Date of Event | 2019-12-28 |
| Date Mfgr Received | 2020-02-18 |
| Device Manufacturer Date | 2012-12-28 |
| 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 | 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 | 2020-03-12 |
| Returned To Mfg | 2020-02-18 |
| 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 | 2020-03-12 |