MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE® RESUSCITATION MODEL 100; CARDIAC CHEST COMPRESSOR

Model Number MODEL 100

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 06/06/2018

Event Type  malfunction  

Manufacturer Narrative

The customer's reported complaint of the autopulse platform displayed user advisory (ua) 41 (patient temperature sensor failure) error message was confirmed in the archive review but not during the initial functional testing.There were no device deficiencies found during the evaluation of the platform, which could have caused or contributed to the reported (ua) 41 error message.Visual inspection was performed and found damaged front enclosure, unrelated to the reported complaint.Following the replacement of front enclosure, the device was further tested and passed all testing criteria with no issues or faults observed.The autopulse platform is a reusable device and was manufactured in oct 2012.It has exceeded its expected service life of 5 years.Review of the archive data show (ua) 41 error messages occurred on the reported event date.Functional testing was performed and found no issue.Additionally, as a precautionary measure, the temperature sensor cabling, the pca power distribution board, and the fan/bracket assembly were replaced.The storage and shift check conditions are not known; however, factors such as ambient storage condition (e.G., a fire truck in sun) or soft surface that may block air vents are known to cause ua 41 error messages in rare cases.Historical complaints were reviewed for service information related to the reported complaint and there was one similar complaint reported for autopulse platform with serial number (b)(4).Ccr (b)(4), reported on (b)(6) 2015.Issue was not confirmed.Ccr (b)(4), reported on (b)(6) 2016.Issue was not confirmed.Ccr (b)(4), reported on (b)(6) 2016.The temperature sensor cabling was replaced.

Event Description

During shift check, autopulse platform ((b)(4)) was displaying an error message user advisory (ua) 41 (patient temperature sensor failure).No patient involvement on this issue.

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: noemi schambach ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192955
• MDR Report Key: 7668390
• MDR Text Key: 113394665
• Report Number: 3010617000-2018-00702
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 07/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1