The autopulse platform in complaint was returned to zoll on 02/27/2015 for investigation.Investigation results as follows: visual inspection was performed and the reported complaint was confirmed.Liquid was observed inside the front panel membrane.The front panel membrane was removed and the liquid was cleaned with isopropanol to remedy the complaint.The bottom enclosure and battery lock were also observed to have been damaged.The platform was functionally tested with a large resuscitation test fixture for 15 minutes and performed as intended.The device passed functional test requirements.The platform's archive data was reviewed and there were no user advisories observed on the reported event date.Based on the investigation, the part(s) identified for replacement were the bottom enclosure and battery lock.In summary, the reported complaint was confirmed during visual inspection.The front panel membrane was removed and the liquid was cleaned with isopropanol to remedy the complaint.Following service, the device passed all testing criteria.
|