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

Model Number MODEL 100

Device Problems Break (1069); Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 01/29/2015

Event Type  malfunction  

Event Description

It was initially reported that one of the patient shoulder restraint hoops was broken and needs to be replaced.No patient involvement was reported.No further information was provided.The autopulse platform was subsequently returned to zoll for investigation.During review of the platform's archive data, it was observed that a user advisory (ua) 18 (max take-up revolutions exceeded) message occurred on the reported event date of (b)(6) 2015.Although the customer did not report this, ua 18 is considered a reportable malfunction.

Manufacturer Narrative

The autopulse platform (s/n (b)(4)) was returned to the manufacturer for evaluation.Visual inspection of the returned platform was performed which found that the top cover and front enclosure were cracked.The bottom enclosure was also found to be damaged and the restraint wires were cut and the battery clip was bent.The platform was functionally tested with a large resuscitation test fixture (lrtf) for 15 minutes, with no user advisories or warnings observed.A review of the platform's archive data was performed which found that a user advisory (ua) 18 (max take-up revolutions exceeded) message occurred on the reported event date of (b)(6) 2015.Per autopulse technical service guide (p/n 11377-006), a ua18 is exhibited when the autopulse has detected that either the patient's chest is too small while sizing the patient (take-up) or that there is no patient on the platform.As the archive did not record a change in the load, it has been concluded that there was no patient on the platform when the ua was exhibited.Based on the investigation the parts identified for replacement were the top cover, battery clip, front enclosure and bottom enclosure.In summary, the initial reported complaint of physical damage to the platforms shoulder restraint was confirmed during visual inspection and may have been attributed to user error, as the wires were cut.Following service, including replacement of the damaged parts, the device passed all testing criteria.

• Brand Name: AUTOPULSE® RESUSCITATION SYSTEM 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: 4728918
• MDR Text Key: 5579677
• Report Number: 3010617000-2015-00265
• Device Sequence Number: 1
• Product Code: DRM
• 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: 01/29/2015

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: 8700-0700-01-66
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2015
• Initial Date FDA Received: 04/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/30/2007
• 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