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? RESUSCITATION MODEL 100 8700-0700-01 manufactured by Zoll Circulation.
[188220518]
During preventive maintenance, the autopulse platform (sn (b)(4)) displayed an error message "system error, out of service, revert to manual cpr". The root cause is due to a defective processor board likely due to normal wear and tear. The autopulse platform is a reusable device and was manufactured in january 2006 and is 14 years old, well beyond the expected service life of 5 years. The platform failed the initial functional testing due to a system error, out of service, revert to manual cpr was observed upon powering on the device. Per archive, the occurred system error was found to be latch error 136-internal parameter corrupted. As part of routine service during testing, the platform was examined and found failed load cell based on the load cell characterization. The load cell was found defective likely as a result of damage sustained due to mishandling. To resolve the issue, the damaged load cell needs to be replaced. Visual inspection was performed and found a damaged screw post to the autopulse platform top cover. This type of damage found during visual inspection is characteristic of normal wear and tear for the life of the device. Last autopulse 1. 1 was manufactured in 2009. As of july 2016, zoll announced end of life for the autopulse 1. 1. Many important components used in ap1. 1 are no longer available further restricting our ability to service. The platform will be returned to the customer without the repair and it will have a label state "not for clinical use". Historical complaints were reviewed for service information related to the reported complaint and there was no similar complaint reported for autopulse platform with serial number (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[188220519]
The autopulse platform (sn (b)(4)) was returned for preventive maintenance. As part of routine service, the device was tested and during functional testing displayed an error message "system error, out of service, revert to manual cpr" on the user control panel.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010617000-2020-00249 |
| MDR Report Key | 9821833 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-11 |
| Date of Report | 2020-03-11 |
| Date of Event | 2020-02-18 |
| Date Mfgr Received | 2020-02-18 |
| Device Manufacturer Date | 2006-01-18 |
| 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 |
| 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 | 2020-03-11 |
| Returned To Mfg | 2020-01-07 |
| Model Number | MODEL 100 |
| Catalog Number | 8700-0700-01 |
| 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 | 2020-03-11 |