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

Model Number MODEL 100

Device Problems Visual Prompts will not Clear (2281); Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 11/24/2015

Event Type  malfunction  

Manufacturer Narrative

The autopulse platform (s/n (b)(4)) was returned to zoll (b)(4) on 12/08/2015.Investigation results as follows: a visual inspection of the returned autopulse platform was performed and a 2 inches cut was noted on the load plate cover.There were no damages observed to the housing.A review of the archive was performed and several user advisories (ua) 7 were noted between 11/2/2015 and 11/30/2015.However there was no activity recorded on the date of event, (b)(6) 2015.The platform was functional tested and the autopulse exhibited user advisor (ua) 7 (discrepancy between load 1 and load 2 too large) upon power up thus confirming the reported complaint.Further investigation indicated that one of the load cells was defective.Replacing the single load cell remedied the ua7.Based on the investigation, load plate cover and a single load cell was replaced.In summary, the customer's reported complaint of the platform exhibiting ua 7 was confirmed during functional testing which was attributed to a defective load cell.After replacement of the parts identified during investigation, the platform passed all final functional testing criteria.

Event Description

Complainant alleged that the autopulse platform displayed a user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) message, that was unable to be cleared.There was no report of any patient involvement.No further details were provided.

• 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: joy patel ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192957
• MDR Report Key: 5320349
• MDR Text Key: 34173828
• Report Number: 3010617000-2015-00695
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000017
• UDI-Public: 00849111000017
• 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: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 8700-0700-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2015
• Initial Date FDA Received: 12/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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