MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-12 for AUTOPULSE? PLATFORM RESUSCITATION MODEL 100 8700-0700-01 manufactured by Zoll Circulation.
[188231052]
The reported complaint of "the autopulse platform (sn (b)(4)) displayed user advisory (ua) 45 (not at "home" position after power-on/restart) error message" was confirmed during the functional testing and the archive data review. The root cause for the ua45 error message was due to the driveshaft not being at home position, which is likely attributed to user error. User advisory is a clearable error message, ua45 alerts the operator that the autopulse driveshaft is not at its home position when the platform was powered on. This user advisory will persist until the driveshaft is returned to its home position. Per the autopulse user guide instruction, to clear ua45, the operator needs to pull up the lifeband until the chest bands are full extended. This action will move the driveshaft to its home position. Upon visual inspection, unrelated to the reported complaint, noticed sticky clutch. The clutch plate was deburred to address the sticky clutch problem. The cause for the observed sticky clutch problem was due to normal wear and tear. The autopulse platform was manufactured in march 2008 and is more than 11 years old, past the expected service life of 5 years. During initial functional testing, the autopulse platform displayed ua45 error message upon powering on. The archive data review showed occurrence of multiple ua45 error message on the reported complaint date. The drive shaft was rotated to home position to clear the ua45 error message. After clearing the ua45 error message, the autopulse platform performed compressions without any fault or error using lrtf (large resuscitation test fixture). Following service, the autopulse platform was subjected to the run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test batteries for 15 minutes without any fault or error. The autopulse platform passed the final testing without any fault or error. Historical complaints were reviewed for service information related to the reported complaint and there were three similar complaint reported for autopulse platform with sn (b)(4). Ccr (b)(4) was reported on (b)(6) 2013, ccr (b)(4) was reported on (b)(6) 2016 and ccr (b)(4) was reported on (b)(6) 2019. The drive shaft was rotated to home position to clear the ua45 error message.
Patient Sequence No: 1, Text Type: N, H10
[188231053]
During shift check, upon powering on, the autopulse platform (sn (b)(4) displayed user advisory (ua) 45 (not at "home" position after power-on/restart) error message. No patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010617000-2020-00261 |
| MDR Report Key | 9826693 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-12 |
| Date of Report | 2020-03-12 |
| Date of Event | 2020-02-20 |
| Date Mfgr Received | 2020-02-20 |
| Device Manufacturer Date | 2007-12-03 |
| 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 | 2020-02-26 |
| 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 | 2020-03-12 |